Galicia South Health Research Institute, Hospital Álvaro Cunqueiro, Technical Block, Floor 2, Roal Clara Campoamor nº 341, 36213 Vigo, Spain.
Aragonese Research Group in Primary Care (GAIAP), Institute of Health Research, Avenue San Juan Bosco, 13, 50009 Zaragoza, Spain.
Int J Environ Res Public Health. 2021 May 28;18(11):5788. doi: 10.3390/ijerph18115788.
We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45-75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions' effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45-75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). In total, 13 control centers ( = 356) and 12 intervention centers ( = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = -0.09 (95% CI: -0.29-0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: -0.32-0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01-0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64-1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55-1.73), no smoking OR = 0.61 (95% CI: 0.54-1.06), EVA adjusted mean difference = -1.26 (95% CI: -4.98-2.45). No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control.
我们评估了个体、群体和社区干预措施对改善 45-75 岁有两种或三种不健康生活习惯的糖尿病患者血糖控制的有效性。作为次要终点，我们评估了干预措施对坚持地中海饮食、身体活动、久坐的生活方式、吸烟和生活质量的影响。这是一项在西班牙进行的 2016 年 1 月至 2019 年 12 月的随机临床聚类（健康中心）试验，采用了两组平行的干预措施。参与者为 45-75 岁有两种以上不健康生活习惯（吸烟、不遵守地中海饮食或很少进行身体活动）的糖尿病患者。中心被随机分配。估计主要结局变量的样本量为 420 人。通过个体、群体和社区干预措施进行为期 12 个月的教育干预，以提高对地中海饮食、身体活动和戒烟的依从性。对照组接受常规医疗保健。结局变量包括：HbA1c（主要）、地中海饮食依从性评分（MEDAS）、国际饮食质量指数（DQI-I）、国际身体活动问卷（IPAQ）、久坐的生活方式、每天吸烟≥1 支和 EuroQol 问卷（EVA-EuroQol5D5L）。共有 13 个对照组（=356）和 12 个干预组（=338）纳入研究，基线条件相似。通过应用多水平混合模型进行意向治疗分析，该模型根据基础值和健康中心进行拟合：HbA1c 调整平均差异=-0.09（95%CI：-0.29-0.10），DQI-I 调整平均差异=0.25（95%CI：-0.32-0.82），MEDAS 调整平均差异=0.45（95%CI：0.01-0.89），中高强度身体活动比值比=1.09（95%CI：0.64-1.86），非久坐生活方式比值比=0.97（95%CI：0.55-1.73），不吸烟比值比=0.61（95%CI：0.54-1.06），EVA 调整平均差异=-1.26（95%CI：-4.98-2.45）。在血糖控制或身体活动、久坐的生活方式、吸烟和生活质量方面均未发现统计学显著变化。多组分的个体、群体和社区干预措施仅显示出在坚持地中海饮食方面有统计学意义的改善。这种创新的干预措施需要进一步研究，以证明其在血糖控制不佳的患者中的有效性。
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