Health literacy and exercise -focused interventions on clinical measurements in Chinese diabetes patients: A cluster randomized controlled trial

Health literacy and exercise -focused interventions on clinical measurements in Chinese diabetes patients: A cluster randomized controlled trial
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健康素养和运动干预对中国糖尿病患者临床测量的影响:一项随机对照试验

DOI:
10.1016/j.eclinm.2019.11.004
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发表时间:
2019-12-01
期刊:
影响因子:
15.1
通讯作者:
Xu, Wanghong
Xu, Wanghong
中科院分区:
医学1区
文献类型:
--
作者:
Wang, Lei;Fang, Hong;Xu, Wanghong

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背景:中国地区糖尿病患者健康素养低,体力活动水平低,可能导致血糖控制不良等临床结局。本研究旨在评价健康素养和运动干预对中国2型糖尿病(T2 DM)患者临床结局的有效性。方法:采用整群随机对照试验,从上海市8个社区的35个门诊招募799例最近一次健康素养(Alc>)=7.5%(或空腹血糖=10 mm ol/L)的T2 DM患者,随机分为1个标准护理(对照)组和3个干预组,分别接受健康素养、运动或两者兼有的干预。分别在基线、干预后3、6、12个月和干预结束后12个月测量主要结局(主要结局)、血压和血脂(次级结局)。本试验在国际标准随机对照试验编号登记处注册,编号为ISRCTN76130594。结果:3个干预组在12个月时(p7.0%或53mmollmo1)的Alc下降幅度大于对照组,健康素养下降0.90%,运动下降0.83%,综合组下降0.54%,每次随访时三个干预组的调整危险比(RR)也明显低于对照组,调整后的风险比(RR)在0.06~0.16之间。然而,从基线到12个月,对照组低密度脂蛋白(LDL)的降幅大于健康素养组(Beta=0.55,p
Background: The diabetes patients in China have low health literacy and low levels of physical activities which may result in the poor glycemic control and other clinical outcomes. This study is designed to evaluate the effectiveness of health literacy and exercise-focused interventions on clinical outcomes among Chinese patients with type 2 diabetes (T2DM).Methods: In this cluster randomized controlled trial, 799 T2DM patients with the most recent Al c >= 7.5% (58 mmol/mol, or fasting glucose level >= 10 mmol/L) were recruited from 35 clinics in 8 communities in Shanghai, China, and randomized into one standard care (control) arm and three intervention arms receiving interventions focused on health literacy, exercise or both. Al c (primary outcome), blood pressure and lipids (secondary outcomes) were measured at baseline, 3-, 6-, 12 -months of intervention period and 12 -months after completion of the interventions. This trial is registered with the International Standard RCT Number Register, number ISRCTN76130594.Findings: The three intervention groups had more reductions in Al c than the control group, with 0.90% reduction in the health literacy, 0.83% in the exercise and 0.54% in the comprehensive group at 12 -months (p7.0% or 53 mmollmol) was also significantly lower in three intervention groups than control group at each follow-up visit, with adjusted risk ratios (RR) ranging from 0.06 to 0.16. However, the control group has greater reductions in low-density lipoprotein (LDL) than the health literacy group from baseline to 12 -months (beta=0.55, p