+1 Recommend
0 collections
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      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)


      Read this article at

          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.


          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.

          Related collections

          Most cited references78

          • Record: found
          • Abstract: not found
          • Article: not found

          Fitting Linear Mixed-Effects Models Usinglme4

            • Record: found
            • Abstract: found
            • Article: found

            Multiple imputation using chained equations: Issues and guidance for practice

            Multiple imputation by chained equations is a flexible and practical approach to handling missing data. We describe the principles of the method and show how to impute categorical and quantitative variables, including skewed variables. We give guidance on how to specify the imputation model and how many imputations are needed. We describe the practical analysis of multiply imputed data, including model building and model checking. We stress the limitations of the method and discuss the possible pitfalls. We illustrate the ideas using a data set in mental health, giving Stata code fragments. 2010 John Wiley & Sons, Ltd.
              • Record: found
              • Abstract: found
              • Article: not found

              Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study.

              To determine the relation between exposure to glycaemia over time and the risk of macrovascular or microvascular complications in patients with type 2 diabetes. Prospective observational study. 23 hospital based clinics in England, Scotland, and Northern Ireland. 4585 white, Asian Indian, and Afro-Caribbean UKPDS patients, whether randomised or not to treatment, were included in analyses of incidence; of these, 3642 were included in analyses of relative risk. Primary predefined aggregate clinical outcomes: any end point or deaths related to diabetes and all cause mortality. Secondary aggregate outcomes: myocardial infarction, stroke, amputation (including death from peripheral vascular disease), and microvascular disease (predominantly retinal photo-coagulation). Single end points: non-fatal heart failure and cataract extraction. Risk reduction associated with a 1% reduction in updated mean HbA(1c) adjusted for possible confounders at diagnosis of diabetes. The incidence of clinical complications was significantly associated with glycaemia. Each 1% reduction in updated mean HbA(1c) was associated with reductions in risk of 21% for any end point related to diabetes (95% confidence interval 17% to 24%, P<0.0001), 21% for deaths related to diabetes (15% to 27%, P<0.0001), 14% for myocardial infarction (8% to 21%, P<0.0001), and 37% for microvascular complications (33% to 41%, P<0.0001). No threshold of risk was observed for any end point. In patients with type 2 diabetes the risk of diabetic complications was strongly associated with previous hyperglycaemia. Any reduction in HbA(1c) is likely to reduce the risk of complications, with the lowest risk being in those with HbA(1c) values in the normal range (<6.0%).

                Author and article information

                Role: Academic Editor
                Role: Academic Editor
                Role: Academic Editor
                Int J Environ Res Public Health
                Int J Environ Res Public Health
                International Journal of Environmental Research and Public Health
                28 May 2021
                June 2021
                : 18
                : 11
                [1 ]Galicia South Health Research Institute, Hospital Álvaro Cunqueiro, Technical Block, Floor 2, Roal Clara Campoamor nº 341, 36213 Vigo, Spain; sabela.couso@ 123456iisgaliciasur.es (S.C.-V.); anaclaveriaf@ 123456gmail.com (A.C.)
                [2 ]Aragonese Research Group in Primary Care (GAIAP), Institute of Health Research, Avenue San Juan Bosco, 13, 50009 Zaragoza, Spain; fatima.lopezmendez@ 123456hotmail.com (F.M.-L.); bmasluk@ 123456unizar.es (B.M.); med000764@ 123456gmail.com (R.M.-B.)
                [3 ]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; donrecio@ 123456gmail.com
                [4 ]Ezkerraldea-Enkarterri-Cruces Integrated Health Organisation, Biocruces Bizkaia Health Research Institute Innovation Unit, Plaza de Cruces s/n, 48903 Barakaldo, Spain; haizea.pomboramos@ 123456osakidetza.eus
                [5 ]Balearic Islands Health Research Institute (IdISBa), Highway Valldemosa 79, 07120 Palma, Spain; aleiva@ 123456ibsalut.caib.es
                [6 ]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; m.gil@ 123456pssjd.org
                [7 ]Psychology Department, Universidad Loyola Andalucía, Avenue of the Universities, s/n, 41704 Dos Hermanas, Spain; emotrico@ 123456uloyola.es
                [8 ]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; rmarti.girona.ics@ 123456gencat.cat
                [9 ]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; francisco.gude.sampedro@ 123456sergas.es
                Author notes
                © 2021 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( https://creativecommons.org/licenses/by/4.0/).


                Public health
                health promotion,diabetes mellitus,exercise,mediterranean diet,tobacco use disorder,primary health care


                Comment on this article