3.1 Publishable summary

Transcription

1 3.1 Publishable summary PROJECT CONTEXT AND OBJECTIVES Type 2 diabetes, formerly known as non insulin dependent diabetes (NIDDM), is one of the fastest growing chronic diseases worldwide. This is primarily due to increasing prevalence of obesity, caused by a sedentary lifestyle and general food abundance. It is estimated that in year 2000 there were approximately 150 million individuals with type 2 diabetes and that this number is likely to double by A major reason for the increased diabetes prevalence is the global obesity epidemic, together addressed as diabesity. The global increase in the prevalence of obesity is most likely driven by a simultaneous increase in global food abundance incl. food of reduced nutritional quality, together with increased sedentariness and decreased physical activity during work and leisure time5. Recent studies have also indicated that a deviation of normal sleeping pattern (7 8 h sleep per night), particularly short sleep, increases appetite and promotes obesity and its related diseases (e.g. type 2 diabetes and cardiovascular diseases). The main objective of PREVIEW (PREVention of diabetes through lifestyle Intervention and population studies in Europe and around the World) is to determine the extent to which a high protein, low Glycaemic Index (GI) diet in combination with moderate or high intensity physical activity can reduce the incidence of diabetes in pre diabetic overweight children, adults, and elderly compared with the currently recommended diet (i.e. less protein and a higher GI). Furthermore, we want to study the interaction of lifestyle factors (diet, physical activity) with sleep and habitual stress as well as behavioural and sociological factors in the prevention of type 2 diabetes. The objectives will be achieved from two distinct lines of evidence: 1) A worldwide, multicentre, clinical randomised intervention trial (RCT) in overweight and obese pre diabetic subjects comparing a high protein low GI diet with the officially recommended diet in 6 EU countries (Denmark, Finland, the Netherlands, United Kingdom, Spain, Bulgaria) and 2 overseas countries (Australia and New Zealand). 2) Longitudinal population studies using data from Europe, New Zealand and Canada with regard to the importance of protein and GI and increased physical activity for prevention of type 2 diabetes in pre diabetic subjects. The role of sleeping pattern and stress as well as behavioural, cultural and socioeconomic factors will be included in both types of study analyses. DESCRIPTION OF THE WORK PERFORMED SINCE THE BEGINNING OF THE PROJECT AND THE MAIN RESULTS ACHIEVED SO FAR The first year of the project has mainly been devoted to preparing the large intervention trial and the protocol in WP1 to be approved by the national Ethical Committees for each intervention centre. Also as part of this preparation, guidelines for the two intervention diets and for the two intervention exercise prescriptions, a cooking book for each one of the two intervention diets, Standard Operation Grant Agreement # PREVIEW UCPH Page 5 of 120

2 Procedures (SOPs) and Instructions to participants have been written and translated to local languages. Electronic Case record forms have been developed, and OpenClinica has been selected and it is used for data entry. Beyond what was originally planned, a Physical Activity Log (PAL) to monitor subjects physical activity electronically has been developed on a separated platform. Figure 1 PREVIEW teaching material The staff in the different intervention centres has been trained in diet and physical activity related matters, as well as in taking diverse measurements. In addition, they have attended a cooking course provided by professional chefs from Meyers Madhus, Copenhagen, Denmark. All centres have started pre screening and screening potential participants. Those eligible ones have been randomised to one of the four intervention groups: 1. High protein, high intensity; 2. Mediumprotein, high intensity; 3. High protein, moderate intensity and 4. Moderate protein, moderate intensity; and have started the 8 weeks weight reduction phase with Cambridge Weight Plan (LCD diet). For population studies (WP2), a document describing the construction of the common database from the participating epidemiological studies: The Netherlands (LifeLines, NQPlus), Finland (Young Finns Study), New Zealand (New Zealand Adult Nutrition Survey) and Canada (The Quebec Family Study), has been produced. Specific measures on sleep in a subset of the intervention trial are done by the University of Maastricht (WP3). They have obtained the Ethical approval from the Medical Ethics Committee of the University Hospital of Maastricht, and afterwards started with the recruitment of subjects to participate in the sleep architecture and brain image tests, oriented to the study of the effect of the sleep and stress. The main goal of WP4 is to analyse moderating or mediating influences of socio ecological variables of behaviour change as well as evaluating socio economic components and the public health impact of the Randomized Clinical Intervention Trial (RCT). To this end, a set of questionnaires has been compiled, and made available electronically through a Questionnaire Delivery Platform (QDP). Regarding the training on behavioural matters, a manual for the instructors has been produced and two training sessions for the instructors have been arranged. In the dissemination work package WP5, the PREVIEW logo and corporate image have been defined and are now used in all project dissemination material. A PREVIEW Website has been developed, Grant Agreement # PREVIEW UCPH Page 6 of 120

3 including both a public and a private section. A PREVIEW flyer and the 1 st Newsletter have been issued. PREVIEW project has been disseminated in several national and international press releases. In addition, the project has been presented in Workshops, Conferences and Symposia, such as the PREVIEW Parallel Symposium within the IUNS 20 th International Congress of Nutrition in Granada, Spain. The PREVIEW Publication rules have been defined. With regards to exploitation matters, PREVIEW IPR policy has been defined. Figure 2 PREVIEW Questionnaire delivery platform (left) and behavioural training session (right) EXPECTED FINAL RESULTS AND POTENTIAL IMPACT AND USE Overall, PREVIEW will test new and unique hypotheses on specific diets and intensities of physical activity on the development of type 2 diabetes over the whole life span. Furthermore, sleep and stress will be used as variables in the multicentre intervention and population studies. Finally, factors for motivation and moderators of behaviour change will be pin pointed. The PREVIEW intervention trial will compare the effects of two diets in a large number of pre diabetic subjects in a multinational intervention trial, while at the same time incorporating physical activity at two different levels. Furthermore, population data analyses will be performed to support the findings of the intervention trial. By comparing the interaction between two different exercise intensities and varying dietary protein and GI, we will create very unique data. The present intervention trial addresses the role of diet and physical activity in maintenance of reduced body weight in an extended period (3 y), hence going beyond the time span of most of the earlier studies. PREVIEW will be able to evaluate the significance of parameters related to sleep duration, sleep quality, stress and physical activity for weight loss and subsequent weight maintenance. A disturbed sleeping pattern resulting in either reduced sleeping time or reduced sleep quality may be related to the development of type 2 diabetes. Stress, especially in interaction with the disturbed sleeping pattern, may emphasize this effect. PREVIEW will assess the costs, effectiveness and benefits of providing extended support, reinforcement and motivation for people at high risk of diabetes to make positive lifestyle changes and maintain these in the longer term. Thereby our research will generate extremely valuable and policyrelevant evidence about prevention practices throughout Europe. Palatability and culinary innovation are key factors for consumer acceptability of less well known foods and dishes, and thereby for the putative societal impact of our research. By involving the highly Grant Agreement # PREVIEW UCPH Page 7 of 120

4 recognized food developers, Meyers Madhus, PREVIEW will teach dieticians how to instruct participants in producing well tasting and acceptable meals based on local foods and cultures. The strategic impact of PREVIEW relates to the massive problems associated with diabesity (obesity and diabetes), as a global health issue and emerging epidemic and includes partners from east, west, north and south Europe, Australia, New Zealand and Canada. The public health and socio economic impact of PREVIEW is therefore expected to be very significant. The PREVIEW project will increase our knowledge on the relationship between lifestyle factors, health and well being, and evidence of the importance of lifestyle in helping to prevent diet related diseases and contribute to healthy ageing of the population in Europe. The establishment of even more optimal regimens to effectively prevent and delay type 2 diabetes and reduce its associated complications will contribute greatly to improve the quality of life of both younger and older subjects and also to a major reduction in healthcare costs. The PREVIEW project aims to improve the health of the European citizens by defining a dietary regime, which in combination with physical activity can prevent the escalation of diabetes and its complications. The project will also evaluate the moderating and/or mediating influence of socialecological variables such as social cognitive determinants of behavioural change and habitual behaviour, social environmental influences, cultural habits, socio ecological and socio economic components, as well as sleeping pattern and chronic stress. Such a cross disciplinary approach makes the project the most ambitious of its kind in Europe. Furthermore, PREVIEW will assess the costs, effectiveness and benefits of providing extended support, reinforcement and motivation for people at high risk of diabetes to make positive lifestyle changes and maintain these in the longer term. Hence, with the potential to identify a more effective, safer, tolerable and so accepted lifestyle for diabetes prevention in a variety of cultures, PREVIEW will inform and influence future health and research policy. The combination of multicentre, multinational intervention and population studies will lead to a greater understanding of how the diabetes epidemic can be curtailed, and how to prevent and treat obesity, cardiovascular disease and their complications in a variety of populations. A specific dissemination strategy, will assure that the findings of PREVIEW will reach the most relevant stakeholder groups, including health and research policy entities, the agricultural sector and food industry, as well as a larger audiences within the general public, ultimately leading to a more effective prevention of type 2 diabetes and its related complications. This in turn, will enable to improve public prevention programmes, as well as the primary and secondary care treatment of the obese and prediabetic population in Europe, including the elderly. The address of the project PREVIEW public website is: Here it can be found information about the project objectives and expected results, involved organisations and principal investigators, work packages, and dissemination material such as the project leaflet and newsletters, among others. Grant Agreement # PREVIEW UCPH Page 8 of 120

5 3.2 Core of the report for the period: Project objectives, work progress and achievements, project management Project objectives for the period The main objective of PREVIEW is to determine the extent to which a high protein, low GI diet in combination with moderate or high intensity physical activity can reduce the incidence of diabetes in pre diabetic overweight children, adults, and elderly compared with the currently recommended diet (i.e. less protein and a higher GI). Furthermore, we want to study the interaction of lifestyle factors (diet, physical activity) with sleep and habitual stress as well as behavioural and sociological factors in the prevention of type 2 diabetes. The objectives will be achieved by combining data from a multicentre, multinational intervention trial and large population studies. Our main objectives in PREVIEW during the first year (First Reporting Period) have been as follows: Objectives corresponding to tasks with termination date within the First Reporting Period (according to DoW): To finalize the preparation phase (Sub objective 1.1) To screen eligible participants for the study (Sub objective 1.2) To compile a single database from the participating epidemiological studies (Sub objective 2.1) To receive the approval from the Medical Ethics committee (METC) for (i) local performance of our part of the tasks in WP1; (ii) research on sleep architecture in a sub cohort of 40 children; (iii) research on brain imaging in a sub cohort of 40 children (Sub objective 3.1) To identify and provide reliable questionnaires (Sub objective 4.1) To enable intervention staff of the 8 RCT centres to help subjects of the RCT to initiate health behaviour change and maintain a healthy life style. Enable staff to create a logic model regarding the intervention (Sub objective 4.3) To make a final establishment of the organisational structure and its bodies (Sub objective 6.1) To organise a flexible and clear meeting structure (Sub objective 6.2) Objectives corresponding to tasks initiated during the First Reporting Period and still in Progress (according to DoW): To complete the 2 month weight reduction phase (including participant supervision and data collection) and to randomize participants for the weight maintenance phase (Sub objective 1.3) To collect, store and analyse data (Sub objective 1.5) To develop a dedicated GI questionnaire (Sub objective 2.2) Recruitment of a sub cohort of 40 children aged years for sleep architecture and 40 children for brain imaging; these sub cohorts may partly overlap (Sub objective 3.2) Identify the mediating role of changes in sleeping pattern (sleep quality and sleep duration) and in stress in possible changes in insulin sensitivity, body composition, waist circumference and body weight changes due to the interventions in the cohort described under WP1 (Subobjective 3.3) Grant Agreement # PREVIEW UCPH Page 9 of 120