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Abstract
Introduction The effects of lifestyle interventions in persons with type 2 diabetes (T2D) on health-related quality of life (HRQoL) and subjective well-being are ambiguous, and no studies have explored the effect of exercise interventions that meet or exceed current recommended exercise levels. We investigated whether a 1-year intensive lifestyle intervention is superior in improving HRQoL compared with standard care in T2D persons.
Research design and methods We performed secondary analyses of a previously conducted randomized controlled trial (April 2015 to August 2016). Persons with non-insulin-dependent T2D (duration ≤10 years) were randomized to 1-year supervised exercise and individualized dietary counseling (ie, ‘U-TURN’), or standard care. The primary HRQoL outcome was change in the 36-item Short Form Health Survey (SF-36) physical component score (PCS) from baseline to 12 months of follow-up, and a key secondary outcome was changes in the SF-36 mental component score (MCS).
Results We included 98 participants (U-TURN group=64, standard care group=34) with a mean age of 54.6 years (SD 8.9). Between-group analyses at 12-month follow-up showed SF-36 PCS change of 0.8 (95% CI −0.7 to 2.3) in the U-TURN group and deterioration of 2.4 (95% CI −4.6 to −0.1) in the standard care group (difference of 3.2, 95% CI 0.5 to 5.9, p=0.02) while no changes were detected in SF-36 MCS. At 12 months, 19 participants (30%) in the U-TURN group and 6 participants (18%) in the standard care group achieved clinically significant improvement in SF-36 PCS score (adjusted risk ratio 2.6, 95% CI 1.0 to 4.5 corresponding to number needed to treat of 4, 95% CI 1.6 to infinite).
Conclusion In persons with T2D diagnosed for less than 10 years, intensive lifestyle intervention improved the physical component of HRQoL, but not the mental component of HRQoL after 1 year, compared with standard care.
Trial registration number NCT02417012.
- diabetes mellitus
- type 2
- exercise
- life style
- quality of life
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Contributors CSM is the main author of the paper and contributed to the design of the study, the analysis and interpretation of data, and the drafting and revision of the manuscript. SMN performed the statistical analysis in R and contributed to interpretation of data and writing of the manuscript. MYJ and RC contributed to the design of the study, interpretation of data, and writing of the manuscript. MRL is the principal investigator of the U-TURN study and contributed to the conception and design of the study, the interpretation of data, and writing of the manuscript. RC, JM, JB, HL, AV, DEL, and BKP contributed to the conception and design of the study and gave final approval of the published version of the manuscript. CSM is the guarantor of this work and as such had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Funding This project was funded by TrygFonden. The Centre for Physical Activity Research (CFAS) is supported by a grant from TrygFonden. The Centre for Inflammation and Metabolism/CFAS is a member of the Danish Center for Strategic Research in Type 2 Diabetes (the Danish Council for Strategic Research, grants 09-067009 and 09-075724). The Contour Next glucose monitors were provided by Bayer, Copenhagen, Denmark. This work was also supported by a grant from the Danish Diabetes Academy, which is supported by the Novo Nordisk Foundation (MRL). In addition, MYJ received funding from Rigshospitalet. RC and SMN's employer, the Parker Institute, Bispebjerg and Frederiksberg Hospital, is supported by core grant (OCAY-18-774-OFIL) from the Oak Foundation.
Disclaimer The funders had no role in design and conduct of the study; collection, analysis, and interpretation of data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Competing interests AV was appointed vice-president for AstraZeneca’s Translational Research and Early Clinical Development during the completion of the study, but remained in the scientific steering committee of this study. RC and SMN’s employer, the Parker Institute, Bispebjerg and Frederiksberg Hospital, is supported by core grant OCAY-13-309 from the Oak Foundation. RC reports receiving personal fees from Abbott, AbbVie, Amgen, Axellus, Bayer HealthCare Pharmaceuticals, Biogen Idec, Bristol-Myers Squibb, Cambridge Weight Plan, Celgene, Eli Lilly, Hospira, Ipsen, Janssen, Laboratoires Expanscience, and Merck Sharp; personal fees from employment from Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, and the University of Southern Denmark; grants pending and grant funding from Axellus, AbbVie, Cambridge Weight Plan, Janssen, and Merck Sharp; and being involved in many healthcare initiatives and research that could benefit from wide uptake of this publication, including Cochrane, Outcome Measures in Rheumatology, International Dermatology Outcome Measures, RADS, and the Grading of Recommendations Assessment, Development and Evaluation Working Group. MRL received personal speaker fees from Novo Nordisk.
Patient consent for publication Not required.
Ethics approval Guidelines from the Helsinki Declaration were followed and the study was approved by the Scientific Ethical Committee at the Capital Region of Denmark. All participants provided oral and written informed consent.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. Proposals should be directed to MRL (mathias.ried-larsen@regionh.dk). To gain access, data requestors will need to sign a data access agreement.
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