000109132 001__ 109132 000109132 005__ 20230519145503.0 000109132 0247_ $$2doi$$a10.3390/ijerph18115788 000109132 0248_ $$2sideral$$a125305 000109132 037__ $$aART-2021-125305 000109132 041__ $$aeng 000109132 100__ $$aRepresas-Carrera, Francisco 000109132 245__ $$aEffectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study) 000109132 260__ $$c2021 000109132 5060_ $$aAccess copy available to the general public$$fUnrestricted 000109132 5203_ $$aIntroduction: 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. Method: 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). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 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). Conclusions: 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. 000109132 536__ $$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00114$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00519$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00565$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00762$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00896$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/01072$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/01133$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/01151$$9info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/01412 000109132 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/ 000109132 590__ $$a4.614$$b2021 000109132 592__ $$a0.814$$b2021 000109132 594__ $$a4.5$$b2021 000109132 591__ $$aPUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH$$b45 / 183 = 0.246$$c2021$$dQ1$$eT1 000109132 593__ $$aPollution$$c2021$$dQ1 000109132 591__ $$aPUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH$$b71 / 210 = 0.338$$c2021$$dQ2$$eT2 000109132 593__ $$aHealth, Toxicology and Mutagenesis$$c2021$$dQ1 000109132 591__ $$aENVIRONMENTAL SCIENCES$$b100 / 279 = 0.358$$c2021$$dQ2$$eT2 000109132 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000109132 700__ $$aCouso-Viana, Sabela 000109132 700__ $$0(orcid)0000-0002-6409-9041$$aMéndez-López, Fátima 000109132 700__ $$aMasluk, Bárbara 000109132 700__ $$0(orcid)0000-0002-5494-6550$$aMagallón-Botaya, Rosa$$uUniversidad de Zaragoza 000109132 700__ $$aRecio-Rodríguez, Jose I. 000109132 700__ $$aPombo, Haizea 000109132 700__ $$aLeiva-Rus, Alfonso 000109132 700__ $$aGil-Girbau, Montserrat 000109132 700__ $$aMotrico, Emma 000109132 700__ $$aMartí-Lluch, Ruth 000109132 700__ $$aGude, Francisco 000109132 700__ $$aClavería, Ana 000109132 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000109132 773__ $$g18, 11 (2021), 5788 [19 pp.]$$pInt. j. environ. res. public health$$tInternational journal of environmental research and public health$$x1661-7827 000109132 8564_ $$s715269$$uhttps://zaguan.unizar.es/record/109132/files/texto_completo.pdf$$yVersión publicada 000109132 8564_ $$s3243620$$uhttps://zaguan.unizar.es/record/109132/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000109132 909CO $$ooai:zaguan.unizar.es:109132$$particulos$$pdriver 000109132 951__ $$a2023-05-18-15:02:21 000109132 980__ $$aARTICLE