一年强化生活方式干预对 2 型糖尿病患者健康相关生活质量和心理健康的改善：U-TURN 随机对照试验的二次分析。
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.
机构信息
The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
出版信息
BMJ Open Diabetes Res Care. 2021 Jan;9(1). doi: 10.1136/bmjdrc-2020-001840.
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.
简介
生活方式干预对 2 型糖尿病（T2D）患者的健康相关生活质量（HRQoL）和主观幸福感的影响尚不清楚，并且尚无研究探讨符合或超过当前推荐运动水平的运动干预的效果。我们研究了为期 1 年的强化生活方式干预与 T2D 患者的标准护理相比，在改善 HRQoL 方面是否更具优势。
研究设计和方法
我们对之前进行的一项随机对照试验（2015 年 4 月至 2016 年 8 月）进行了二次分析。非胰岛素依赖型 T2D（病程≤10 年）患者被随机分为 1 年的监督运动和个体化饮食咨询（即“U-TURN”）或标准护理组。主要 HRQoL 结局是从基线到 12 个月随访时 36 项简短健康调查（SF-36）物理成分评分（PCS）的变化，关键次要结局是 SF-36 心理成分评分（MCS）的变化。
结果
我们纳入了 98 名参与者（U-TURN 组=64 名，标准护理组=34 名），平均年龄为 54.6 岁（SD 8.9）。12 个月随访时的组间分析显示，U-TURN 组的 SF-36 PCS 变化为 0.8（95%CI -0.7 至 2.3），而标准护理组则恶化了 2.4（95%CI -4.6 至 -0.1）（差异为 3.2，95%CI 0.5 至 5.9，p=0.02），而 SF-36 MCS 无变化。12 个月时，U-TURN 组有 19 名参与者（30%）和标准护理组有 6 名参与者（18%）的 SF-36 PCS 评分达到临床显著改善（调整后的风险比 2.6，95%CI 1.0 至 4.5，相应的需要治疗人数为 4，95%CI 1.6 至无限）。
结论
在病程不足 10 年的 T2D 患者中，与标准护理相比，强化生活方式干预在 1 年后可改善 HRQoL 的生理成分，但不能改善心理成分。
试验注册
NCT02417012。
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