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Randomized Controlled Trial
. 2021 Jan;9(1):e001840.
doi: 10.1136/bmjdrc-2020-001840.

One-year intensive lifestyle intervention and improvements in health-related quality of life and mental health in persons with type 2 diabetes: a secondary analysis of the U-TURN randomized controlled trial

Christopher Scott MacDonald  1   2   3 , Sabrina M Nielsen  3   4 , Jakob Bjørner  5   6   7 , Mette Y Johansen  8 , Robin Christensen  3   4 , Allan Vaag  9 , Daniel E Lieberman  10 , Bente Klarlund Pedersen  8 , Henning Langberg  2 , Mathias Ried-Larsen  8 , Julie Midtgaard  2   11
Affiliations
Randomized Controlled Trial

One-year intensive lifestyle intervention and improvements in health-related quality of life and mental health in persons with type 2 diabetes: a secondary analysis of the U-TURN randomized controlled trial

Christopher Scott MacDonald et al. BMJ Open Diabetes Res Care. 2021 Jan.

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.

Keywords: diabetes mellitus; exercise; life style; quality of life; type 2.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Flow of participants through the study. BMI, body mass index; HbA1c, glycated hemoglobin A1c; StC, standard care.
Figure 2
Figure 2
Time-course data of the mean changes in SF-36 PCS for the intention-to-treat (ITT) population (A) and the per-protocol population (B). Solid points indicate the intervention group whereas open points indicate the standard care group. The error bars indicate SEs. Least squares means estimates are from repeated measures mixed models with no imputations of missing data. PCS, physical component score; SF-36, 36-item short form health survey.
See this image and copyright information in PMC

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