行为干预对 2 型糖尿病患者采用并维持积极生活方式对心理幸福感和生活质量的影响：IDES_2 随机临床试验。

Effect of a Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle on Psychological Well-Being and Quality of Life in Patients with Type 2 Diabetes: The IDES_2 Randomized Clinical Trial.

机构信息

Centre for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara, Italy.

Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, S. Maria Imbaro, Italy.

出版信息

Sports Med. 2022 Mar;52(3):643-654. doi: 10.1007/s40279-021-01556-0. Epub 2021 Oct 1.

DOI:10.1007/s40279-021-01556-0

PMID:34599476

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8891112/

Abstract

BACKGROUND

Psychological well-being and quality of life (QoL) are important outcomes of lifestyle interventions, as a positive impact may favour long-term maintenance of behaviour change.

OBJECTIVE

This study investigated the effect of a behavioural intervention for adopting and maintaining an active lifestyle on psychological well-being and health-related QoL in individuals with type 2 diabetes.

METHODS

Three hundred physically inactive and sedentary patients were randomized 1:1 to receive 1 month's theoretical and practical counselling once a year (intervention group, INT) or standard care (control group, CON) for 3 years. Psychological well-being and QoL, assessed using the World Health Organization (WHO)-5 and the 36-Item Short Form (SF-36) questionnaire, respectively, were pre-specified secondary endpoints. The primary endpoint was sustained behaviour change, as assessed by accelerometer-based measurement of physical activity (PA) and sedentary time.

RESULTS

WHO-5 and SF-36 physical and mental component summary (PCS and MCS) scores increased progressively in the INT group and decreased in the CON group, resulting in significant between-group differences (WHO-5: mean difference 7.35 (95% confidence interval (CI) 3.15-11.55), P = 0.0007; PCS 4.20 (95% CI 2.25-6.15), P < 0.0001; MCS 3.04 (95% CI 1.09-4.99), P = 0.0025). Percentage of participants with likely depression decreased in the INT group and increased in the CON group. PA volume changes were independently associated with WHO-5 changes, which were significantly higher in participants who accumulated > 150 min·wk of moderate-to-vigorous intensity PA versus those who did not (13.06 (95% CI 7.51-18.61), P < 0.0001), whereas no relationship was detected for QoL.

CONCLUSION

A counselling intervention that was effective in promoting a sustained change in PA and sedentary behaviour significantly improved psychological well-being and QoL.

TRIAL REGISTRATION

ClinicalTrials.gov; NCT01600937; 10 October 2012.

摘要

背景

心理幸福感和生活质量（QoL）是生活方式干预的重要结果，因为积极的影响可能有利于长期维持行为改变。

目的

本研究调查了针对 2 型糖尿病患者的积极生活方式的行为干预对心理幸福感和健康相关 QoL 的影响。

方法

300 名身体不活跃和久坐的患者被随机 1：1 分为接受 1 个月的理论和实践咨询，每年一次（干预组，INT）或标准护理（对照组，CON）3 年。使用世界卫生组织（WHO）-5 和 36-Item Short Form（SF-36）问卷分别评估心理幸福感和 QoL，这是预先指定的次要终点。主要终点是通过加速度计测量的身体活动（PA）和久坐时间的持续行为改变。

结果

INT 组的 WHO-5 和 SF-36 生理和心理成分综合（PCS 和 MCS）评分逐渐增加，CON 组评分下降，导致两组之间存在显著差异（WHO-5：平均差异 7.35（95%置信区间（CI）3.15-11.55），P=0.0007；PCS 4.20（95% CI 2.25-6.15），P<0.0001；MCS 3.04（95% CI 1.09-4.99），P=0.0025）。INT 组中可能患有抑郁症的参与者比例下降，而 CON 组中这一比例上升。PA 量的变化与 WHO-5 的变化独立相关，与未达到 150 分钟·周以上中高强度 PA 的参与者相比，达到或超过这一水平的参与者的 WHO-5 变化显著更高（13.06（95% CI 7.51-18.61），P<0.0001），而 QoL 则没有相关性。