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PREVIEW Report Summary

Project ID: 312057
Funded under: FP7-KBBE
Country: Denmark

Periodic Report Summary 3 - PREVIEW (PREVention of diabetes through lifestyle Intervention and population studies in Europe and around the World)

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 2025. 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.
Project Results:
Work has been done according to plan, and all goals for the 3rd Reporting Period have been achieved. A description of the work performed so far per work package is presented below:

WP1: Multicentre Intervention
The first year of the project was mainly devoted to preparing the large intervention trial and the protocol in WP1 to be approved by the national Ethical Committees for each intervention centre. 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 Procedures (SOPs) and Instructions to participants were written and translated to local languages. Electronic Case record forms were developed, and OpenClinica was selected for data entry. The staff in the different intervention centres has been trained.
All centres pre-screened and screened potential participants. Those eligible subjects started the 8 weeks weight-reduction phase with Cambridge Weight Plan (Low Calorie Diet-LCD) (adults) or with a traditional diet (children/adolescents) and were randomised to one of the four intervention groups. In total, 15,611 adult participants were pre-screened, 5,474 were screened and 2,348 were included. The average weight-loss success was 79% (1,842 subjects, corresponding to 99.5 of the estimated goal). All centres have completed CID5. Compared to the baseline (CID1) participation, about 51% of the participants are still left. With regards to the children/adolescents intervention, of 2 y duration, 139 participants attended CID1. CID4 is almost completed. Minimizing the number of drop-outs is one of our biggest challenges, and several strategies are in place.
WP2: Population studies
During the first year of the project, a document describing the construction of the common database from the participating epidemiological studies: The Netherlands (LifeLines, NQPlus), Finland (Young FinnsStudy), New Zealand (New Zealand Adult Nutrition Survey) and Canada (The Quebec Family Study), was produced.
A food frequency questionnaire (FFQ) was developed to assess GI and GL of the diet. It was sent to ca. 1,600 participants in the NQplus study in Apr-2015.
Association analyses have so far shown that protein as a single factor was predominantly associated with a higher odds of having diabetes, whereas GI and GL showed mixed results in the different cohorts. Moderate physical activity and sleep were associated with a lower odds of having diabetes..
A diet protein scoring tool based on quantity and quality of protein consumed has been developed. The association between the protein score and HbA1c as well as renal function (eGFR) was examined.
WP3: The role of sleep and stress
Specific measures on sleep in a subset of the intervention trial are done by the University of Maastricht (WP3). The adults for the study related to WP3 on the role of sleep and stress have been recruited under WP1 (n=2,326).
Results indicate that sleep and stress are not independently related to insulin resistance at baseline (CID1), not in men, nor in women. Profile of Mood Status shows an independent relationship with insulin sensitivity, i.e. a positive relation with Fatigue in women, and an inverse relation with Vigour in men.
At CID1, 80 children underwent polysomnography and at CID4, 37 children participated; two more have been planned. Data include Total Sleeping Time, Sleep Efficiency, Slow Wave Sleep, and REM-sleep.
At CID1, 43 adults underwent brain-imaging and at CID3, 41 participated. At CID6, 24 adults have been scanned and a total of 29 is planned. The analysis on data from CID1 shows that Brain Reactivity to Food Cues is Positively Related to Insulin Resistance and Negatively Related to Dietary Restraint and Habitual Activity.
The study of the Quebec Family Study (QFS) within WP3 aimed at investigating the relationship between reported daily sleep duration and glucose-insulin homeostasis, as reflected by variations in HOMA-IR. The results show that there is no difference in sleep duration between individuals differing in their HOMA-IR profile in the QFS. The insulin response to glucose is highly correlated with body composition in men and in women in the QFS. Protein intake, physical activity, and sleep duration did not contribute to the insulin response to glucose.
WP4: Other lifestyle variables
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 was compiled, and made available electronically through a Questionnaire Delivery Platform (QDP). Regarding the training on behavioural matters, a manual for the instructors was produced and two training sessions for the instructors were arranged during the first year of the project.
Setting up the technical procedure for the data exchange via the Questionnaire Delivery Platform (QDP) and defining a theoretical framework for the data analysis, were realised as intended. During the 3rd reporting period work has expanded as planned, using data from the QDP for analysing and interpreting the socio-economic and “other life style variables” data out of the RCT (WP1).
WP5: Dissemination and exploitation
During the first year of the project, the corporate image of the project was defined (log, flyer and templates), and the PREVIEW website was developed.
The 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 IUNS 2013and EOS 2016).The PREVIEW Publication rules and the IPR policy have been defined. Seven project newsletters have been produced and distributed. A successful “PREVIEW Summer School” was held in August 2016 in San Sebastian, Spain. There have been several exchanges of students.
A manuscript, describing the PREMIT behaviour modification toolbox has been published. The first manuscript on PREVIEW methods/protocol has been finalised and submitted to Food and Nutrition Research.
WP6: Management
There has been regular communication and reporting to the Commission as well as within the Consortium. So far 5 General Assembly meetings, as well as several Steering Committee Meetings have been held. The EC has assessed the progress of the project in two interim review meetings.
During the 2nd reporting period, an amendment to the contract was achieved that granted a 12 months extension of the recruitment period in WP1 and overall project.
Potential Impact:
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 uses an extended period (3 y), hence going beyond the timespan of most earlier studies.
PREVIEW will also 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. 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 policy-relevant 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 recognized food developers, Meyers Madhus, PREVIEW has taught dieticians how to instruct participants in producing well-tasting and acceptable meals based on local foods and cultures.
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.
Information about the project objectives and expected results can be found in including involved organisations and principal investigators, work packages, and dissemination material.
List of Websites:

Reported by

Københavns Universitet
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