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, Ana Clavería

Journal: International journal of environmental research and public health 2021;18(11):5788

PMID: 34071171

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Plain Language Summary

Life habits such as smoking, physical activity, and diet affect glycaemic control. The objective of this multicentre randomised cluster trial (EIRA study) was to evaluate the effectiveness of multicomponent educational interventions on glycaemic control in Type 2 diabetic patients. Interventions in multicomponent individual, group and community settings included smoking cessation, the Mediterranean diet and physical activity, as well as an assessment of the quality of life. Participants had unhealthy lifestyles prior to the intervention. The study was conducted in 26 primary healthcare centres in seven health departments in Spain over a period of 12 months. A brief intervention aimed to change the habits of the participants, including increasing physical activity, quitting smoking and adhering to the Mediterranean diet. After 12 months of intervention, there were no statistically significant improvements in glycaemic control, physical activity, sedentary lifestyle, smoking, or quality of life. However, adherence to the Mediterranean diet was statistically significant. Further research is needed to determine the effectiveness of multicomponent interventions in improving glycaemic control. The clinical applicability of multicomponent interventions to tackle type 2 diabetes, obesity, and unhealthy lifestyles should be considered by healthcare providers.

Abstract

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.

Address: 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.; 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.; Ezkerraldea-Enkarterri-Cruces Integrated Health Organisation, Biocruces Bizkaia Health Research Institute Innovation Unit, Plaza de Cruces s/n, 48903 Barakaldo, Spain.; Balearic Islands Health Research Institute (IdISBa), Highway Valldemosa 79, 07120 Palma, Spain.; 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.; Psychology Department, Universidad Loyola Andalucía, Avenue of the Universities, s/n, 41704 Dos Hermanas, Spain.; 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.; 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.

DOI: 10.3390/ijerph18115788