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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
Sports Medicine ( IF 9.8 ) Pub Date : 2021-10-01 , DOI: 10.1007/s40279-021-01556-0
Antonio Nicolucci 1, 2 , Jonida Haxhi 3, 4, 5 , Valeria D'Errico 3, 4, 5 , Massimo Sacchetti 6 , Giorgio Orlando 6, 7 , Patrizia Cardelli 3, 8 , Martina Vitale 3, 4 , Lucilla Bollanti 3, 4 , Francesco Conti 3, 4 , Silvano Zanuso 9, 10 , Giuseppe Lucisano 1, 2 , Stefano Balducci 3, 4, 5 , Giuseppe Pugliese 3, 4 ,
Affiliation  

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−1 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.



中文翻译:

采用和维持积极的生活方式的行为干预对 2 型糖尿病患者心理健康和生活质量的影响:IDES_2 随机临床试验

背景

心理健康和生活质量 (QoL) 是生活方式干预的重要结果,因为积极影响可能有利于行为改变的长期维持。

客观的

本研究调查了采用和维持积极生活方式的行为干预对 2 型糖尿病患者的心理健康和健康相关生活质量的影响。

方法

300 名身体不活动和久坐的患者以 1:1 的比例随机分配接受为期 3 年的一年一次(干预组,INT)或标准护理(对照组,CON)为期 1 个月的理论和实践咨询。分别使用世界卫生组织 (WHO)-5 和 36 项简表 (SF-36) 问卷评估的心理健康和生活质量是预先指定的次要终点。主要终点是持续的行为改变,通过基于加速度计的身体活动 (PA) 和久坐时间的测量来评估。

结果

WHO-5 和 SF-36 身心成分总结(PCS 和 MCS)评分在 INT 组中逐渐增加,在 CON 组中下降,导致显着的组间差异(WHO-5:平均差 7.35(95% 置信度)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)。患有可能抑郁症的参与者百分比在 INT 组中下降,在 CON 组中增加。PA 体积变化与 WHO-5 变化独立相关,累积 > 150 min·wk -1的中度至高强度 PA 的参与者与未累积的参与者相比显着更高 (13.06 (95% CI 7.51–18.61) , < 0.0001),而没有检测到 QoL 的关系。

结论

有效促进 PA 和久坐行为持续变化的咨询干预显着改善了心理健康和生活质量。

试用注册

临床试验.gov;NCT01600937;2012 年 10 月 10 日。

更新日期:2021-10-02
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