Effectiveness 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)

Represas-Carrera, Francisco ; Couso-Viana, Sabela ; Méndez-López, Fátima ; Masluk, Bárbara ; Magallón-Botaya, Rosa (Universidad de Zaragoza) ; Recio-Rodríguez, Jose I. ; Pombo, Haizea ; Leiva-Rus, Alfonso ; Gil-Girbau, Montserrat ; Motrico, Emma ; Martí-Lluch, Ruth ; Gude, Francisco ; Clavería, Ana

Resumen: Introduction: 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.

Idioma: Inglés

DOI: 10.3390/ijerph18115788

Año: 2021

Publicado en: International journal of environmental research and public health 18, 11 (2021), 5788 [19 pp.]
ISSN: 1661-7827

Factor impacto JCR: 4.614 (2021)

Categ. JCR: PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH rank: 45 / 183 = 0.246 (2021) - Q1 - T1
Categ. JCR: PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH rank: 71 / 210 = 0.338 (2021) - Q2 - T2
Categ. JCR: ENVIRONMENTAL SCIENCES rank: 100 / 279 = 0.358 (2021) - Q2 - T2

Factor impacto CITESCORE: 4.5 - Medicine (Q2) - Environmental Science (Q2)

Factor impacto SCIMAGO: 0.814 - Pollution (Q1) - Health, Toxicology and Mutagenesis (Q1)

Financiación: info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00114
Financiación: info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00519
Financiación: info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00565
Financiación: info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00762
Financiación: info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/00896
Financiación: info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/01072
Financiación: info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/01133
Financiación: info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/01151
Financiación: info:eu-repo/grantAgreement/ES/ISCIII-MINECO/PI15/01412

Tipo y forma: Article (Published version)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)