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)

Francisco Represas-Carrera, Sabela Couso-Viana, Fátima Méndez-López, Bárbara Masluk, Rosa Magallón-Botaya, Jose I. Recio-Rodríguez, Haizea Pombo, Alfonso Leiva-Rus, Montserrat Gil-Girbau, Emma Motrico, Ruth Martí-Lluch, Francisco Gude and Ana Clavería
Additional contact information
Francisco Represas-Carrera: Galicia South Health Research Institute, Hospital Álvaro Cunqueiro, Technical Block, Floor 2, Roal Clara Campoamor nº 341, 36213 Vigo, Spain
Sabela Couso-Viana: Galicia South Health Research Institute, Hospital Álvaro Cunqueiro, Technical Block, Floor 2, Roal Clara Campoamor nº 341, 36213 Vigo, Spain
Fátima Méndez-López: Aragonese Research Group in Primary Care (GAIAP), Institute of Health Research, Avenue San Juan Bosco, 13, 50009 Zaragoza, Spain
Bárbara Masluk: Aragonese Research Group in Primary Care (GAIAP), Institute of Health Research, Avenue San Juan Bosco, 13, 50009 Zaragoza, Spain
Rosa Magallón-Botaya: Aragonese Research Group in Primary Care (GAIAP), Institute of Health Research, Avenue San Juan Bosco, 13, 50009 Zaragoza, Spain
Jose I. Recio-Rodríguez: San Juan Health Centre, Salamanca Primary Care Research Unit (APISAL), Institute of Biomedical Research of Salamanca (IBSAL), Department of Nursing and Physiotherapy (University of Salamanca), Avenue Portugal 83, 2 Floor, 37005 Salamanca, Spain
Haizea Pombo: Ezkerraldea-Enkarterri-Cruces Integrated Health Organisation, Biocruces Bizkaia Health Research Institute Innovation Unit, Plaza de Cruces s/n, 48903 Barakaldo, Spain
Alfonso Leiva-Rus: Balearic Islands Health Research Institute (IdISBa), Highway Valldemosa 79, 07120 Palma, Spain
Montserrat Gil-Girbau: Research Group in Health Technology Assessment in Primary Care and Mental Health (PRISMA), Research and Development Unit, Institut de Recerca Sant Joan de Déu, Parc Sanitari Sant Joan de Déu, Street Dr. Antoni Pujadas, 42, 08830 Sant Boi de Llobregat, Spain
Emma Motrico: Psychology Department, Universidad Loyola Andalucía, Avenue of the Universities, s/n, 41704 Dos Hermanas, Spain
Ruth Martí-Lluch: Girona Research Support Unit, Jordi Gol i Gurina University Institute for Research in Primary Health Care Foundation (IDIAPJGol), Street Maluquer Salvador 11, 17002 Girona, Spain
Francisco Gude: Clinical Epidemiology Unit, Research Methods Group, Santiago Institute of Sanitary Research (IDIS), Complejo Hospitalario Universitario de Santiago, Travesía da Choupana, s/n, 157056 Santiago de Compostela, Spain
Ana Clavería: Galicia South Health Research Institute, Hospital Álvaro Cunqueiro, Technical Block, Floor 2, Roal Clara Campoamor nº 341, 36213 Vigo, Spain

IJERPH, 2021, vol. 18, issue 11, 1-19

Abstract: 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.

Keywords: health promotion; diabetes mellitus; exercise; Mediterranean diet; tobacco use disorder; primary health care (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
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