WORK PERFORMED AND MAIN RESULTS
Period 2: Jan 1st 2014 to June 30th 2015
A large part of the project efforts, both during the second reporting period, as well as during the whole project duration are devoted to WP1 activities (aprox. 75% of the workload). WP1, the multicentre, multinational study has been very productive in this reporting period (M13-M30). No official deliverables have been submitted during this period, but 16 monthly reports have been sent to the Commission.
All 8 RCT centres have continued to intensively pre-screen, screen participants and start the intervention. Those eligible subjects have started the 8 weeks weight-reduction phase with Cambridge Weight Plan (Low Calorie Diet-LCD) (adults) or with a traditional diet (children/adolescents) and have been randomised to one of the four intervention groups. By month 30, all centres have completed the screening phase and the first 2 months (low-calorie diet/weight reduction) of the intervention. Some of the study centres have already reached 2y intervention for some of their subjects.
In total, 15,611 adult participants have been pre-screened, 5,474 have been screened and 2,348 have been included. The average weight-loss success has been 79% (1,842 subjects, corresponding to 99.5 of the estimated goal). The children recruitment is ongoing and as per 30-Jun-2015, 82 children/adolescents have been randomized. We expect to reach the goal (125 subjects) by the end of 2015.
In relation to WP2, data analysis plan has been written and the first data analysis on the five included cohorts in WP2 (New Zealand Adult Nutrition Survey, Quebec Family Study, Young Finns Study, NQplus, and LifeLines) has been performed on the association between protein as a single factor for prediabetes and diabetes.
Furthermore, a food frequency questionnaire (FFQ) has been developed to assess GI and GL of the diet. This FFQ has been based upon a comprehensive literature overview and on the food items that contribute most to the GI and GL of the Dutch diet. The GI-FFQ is an online questionnaire developed within the “Dutch FFQ-tool” and has been sent out to ca. 1,600 participants in the NQplus study in Apr-2015.
The recruitment of a sub-cohort of 40 children ages 10-18 years for sleep architecture and 40 adults for brain imaging has been achieved, including a number of 19 adults for the high-protein diet and 21 for the moderate protein diet. The first analyses have been performed.
The tasks necessary to complete the objectives, such as setting up the technical procedure for the data exchange via the Questionnaire Delivery Platform and the Physical Activity Log as well as defining a theoretical framework for the data analysis in the RCT and the cohort study, were realized as intended. Most of the relevant data for the analysis of behavioural and sociological data in WP4 (as well as for WP1) are gathered through the QDP.
All tasks in the dissemination and exploitation work package (WP5) have been active during the reporting period, and will continue up to the end of the project.
The second, third and fourth Newsletter have been produced and a document summarizing the oral presentations and workshops at national/international meetings which occurred during M13-M24 and M24-M30 has been submitted. The PREVIEW Publication rules have also been slightly revised.
The activities associated to Task T.6.3 Establishment and maintenance of regular reporting to the Commission including all meetings activities and communication with the Consortium have continued during the 2nd Reporting Period. One General Assembly meeting has been held, as well as several Steering Committee Meetings.
During this period, an amendment to the contract was achieved that granted a 12 months extension of the recruitment period in WP1 and overall project. Managing the increasing number of abstracts and synopses has also been an important task.