The effectiveness of a community-based, type 2 diabetes prevention programme on health-related quality of life. The DE-PLAN study

Georgios Karamanakos, Bernardo Costa-Pinel, Aleksandra Gilis-Januszewska, Dzilda Velickiene, Francisco Barrio-Torrell, Xavier Cos-Claramunt, Santiago Mestre-Miravet, Beata Piwońska-Solska, Alicja Hubalewska-Dydejczyk, Jaakko Tuomilehto, Stavros Liatis, Konstantinos Makrilakis, Georgios Karamanakos, Bernardo Costa-Pinel, Aleksandra Gilis-Januszewska, Dzilda Velickiene, Francisco Barrio-Torrell, Xavier Cos-Claramunt, Santiago Mestre-Miravet, Beata Piwońska-Solska, Alicja Hubalewska-Dydejczyk, Jaakko Tuomilehto, Stavros Liatis, Konstantinos Makrilakis

Abstract

Background and aims: The DE-PLAN was a European multicenter study, with the primary objective of testing whether a community-based lifestyle modification programme could serve as a means of primary prevention for type 2 diabetes (T2D) in high-risk individuals (based on the FINDRISC questionnaire). The aim of this study was to examine the impact of a 1-year community-based lifestyle intervention on health-related quality of life (HRQOL) in individuals from four participating European centers (Athens, Barcelona, Krakow, Kaunas), through a post-hoc analysis.

Materials and methods: Each center was allowed to implement different intervention strategies specifically tailored to the needs of their corresponding population sample. Before and after the intervention, participants underwent clinical evaluation, anthropometric measurements, an oral glucose tolerance test and lipid profile measurements. Health-related quality of life was assessed using the validated HRQOL-15D questionnaire. A difference of ±0.015 in the 15D questionnaire score was set as the threshold of clinically meaningful change.

Results: Data from 786 participants (67% females, mean age 59.7±9.4 years, BMI 31.5±4.5 kg/m2) with complete data regarding the HRQOL were analyzed (Athens: 104, Barcelona: 434, Krakow: 175, Kaunas: 70). After 1 year, a significant overall improvement in HRQOL was shown, as depicted by a change of 15D score from baseline value (0.88±0.9) to post-intervention (0.90±0.87, P<0.001), achieving the threshold of clinically meaningful change. A significant weight reduction was also observed (-0.8±4.0 kg, P<0.001). In multivariate analysis, improvement in HRQOL was independently associated with lower 15D score at baseline (P<0.001) and self-reported increase in overall exercise time (P<0.001) as assessed through specifically designed trial questionnaires.

Conclusion: A community-based lifestyle intervention programme aiming at T2D prevention, applied on a heterogeneous population and with varied methods, was shown to improve overall health-related quality of life to a clinically meaningful degree.

Conflict of interest statement

Athens, Greek arm of the study: This project was funded by the Commission of the European Communities, Directorate C–Public Health, grant agreement no. 2004310. Under the rules of the agreement, it was also cofunded by the private sector and, in this case, it was supported by an unrestricted educational grant from Bristol–Myers–Squibb,Greece. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Flow chart depicting the size…
Fig 1. Flow chart depicting the size of the cohort of participants during the successive steps of the study, from screening to completion.
FINDRISC: Finnish type 2 diabetes risk score, OGTT: Oral glucose tolerance test.

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