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

PLoS One. 2019 Oct 11;14(10):e0221467. doi: 10.1371/journal.pone.0221467. eCollection 2019.

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Aged
  • Diabetes Mellitus, Type 2 / epidemiology
  • Diabetes Mellitus, Type 2 / prevention & control*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Public Health
  • Quality of Life*
  • Risk Reduction Behavior*
  • Surveys and Questionnaires*

Grants and funding

Athens, Greek arm of the study: This project is 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. Barcelona, Catalonian-Spanish arm of the study: The original DE-PLAN-CAT project was funded by Institute of Health Carlos III [www.isciii.es], Spanish Ministry of Health (grant agreements FIS PI05-033 and PS09-001112), and the Department of Health, Generalitat de Catalunya. Current DE-PLAN-CAT translational project (DP-TRANSFERS) has been funded by: (1) Institute of Health Carlos III [www.isciii.es], Spanish Ministry of Health and the European Regional Development Fund (ERDF/FEDER): grant agreements PI14/00122 and PI14/00124, (2) La Marató de TV3[www.ccma.cat/tv3/marato/] Foundation (2015 grant agreement 73-201609.10), (3) Spanish Diabetes Society (2015 Guido Ruffino grant on therapeutic education) [www.sediabetes.org] and (4) Department of Health, Generalitat de Catalunya and the PERIS (Pla Estratègic de Recerca i Innovació en Salut) 2016-2020 [http://canalsalut.gencat.cat/ca/salut-a-z/d/diabetis/prevencio/.], grant agreements SLT002/16/00045, SLT002/16/00154 and SLT002/16/00093. Krakow, Polish arm of the study: The study was funded by The Commission of the European Communities, Directorate C – Public Health, grant agreement no. 2004310 to Jaakko Tuomilehto, supported by The Ministry of Science and Higher Education in Poland, grant agreement no. 40/PUBLIC HEALTH 2004/2006/7 to Zbigniew Szybiński. Kaunas, Lithuanian arm of the study: the project original DE-PLAN was funded by European Communities Directorate, Public Health grant agreement No. 2004310, supported by Lithuanian University Health Sciences Institute of Endocrinology own resources. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.