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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, F, Couso-Viana, S, Méndez-López, F, Masluk, B, Magallón-Botaya, R, Recio-Rodríguez, JI, Pombo, H, Leiva-Rus, A, Gil-Girbau, M, Motrico, E, et al
International journal of environmental research and public health. 2021;18(11)
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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
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.
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Mediators of Lifestyle Behaviour Changes in Obese Pregnant Women. Secondary Analyses from the DALI Lifestyle Randomised Controlled Trial.
van Poppel, MN, Jelsma, JGM, Simmons, D, Devlieger, R, Jans, G, Galjaard, S, Corcoy, R, Adelantado, JM, Dunne, F, Harreiter, J, et al
Nutrients. 2019;11(2)
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Obesity in pregnancy is rising and is associated with increased risks for both mother and baby. In particular, obese women and women with excess weight gain during pregnancy are at an increased risk for developing gestational diabetes (GDM). A better understanding of what drives behaviour change in obese pregnant women is needed to improve the effectiveness of lifestyle interventions such as dietary changes. In this randomised controlled trial, researchers set out to assess what factors might support behaviour change in pregnant women at risk of GDM. A total of 436 women, with pre-pregnancy body mass index of ≥29 kg/m², without GDM, were split into four groups: three of them received counselling based on motivational interviewing (MI) on 1) healthy eating and physical activity, 2) healthy eating alone or 3) physical activity alone, whilst the fourth group received their usual care. Physical activity and food intake were measured at the start of the study, and at 24-28 and 35-37 weeks of pregnancy. Social and psychological factors such as outcome expectancy, risk perception, task self-efficacy (peoples’ confidence to succeed in a specific situation) and social support were measured at those same time points and considered as possible mediators of intervention effects on lifestyle. All three groups that received MI demonstrated an increased positive outcome expectancy for GDM reduction, perceived risk to the baby and increased task self-efficacy. Women with higher self-efficacy tended to be more physically active and consumed less sugary drinks and smaller portion sizes. The authors concluded that motivational interviewing was successful in increasing outcome expectancy and task self-efficacy, both of which were related to improvements in diet and physical activity.
Abstract
A better understanding of what drives behaviour change in obese pregnant overweight women is needed to improve the effectiveness of lifestyle interventions in this group at risk for gestational diabetes (GDM). Therefore, we assessed which factors mediated behaviour change in the Vitamin D and Lifestyle Intervention for GDM Prevention (DALI) Lifestyle Study. A total of 436 women, with pre-pregnancy body mass index ≥29 kg/m², ≤19 + 6 weeks of gestation and without GDM, were randomised for counselling based on motivational interviewing (MI) on healthy eating and physical activity, healthy eating alone, physical activity alone, or to a usual care group. Lifestyle was measured at baseline, and at 24⁻28 and 35⁻37 weeks of gestation. Outcome expectancy, risk perception, task self-efficacy and social support were measured at those same time points and considered as possible mediators of intervention effects on lifestyle. All three interventions resulted in increased positive outcome expectancy for GDM reduction, perceived risk to the baby and increased task self-efficacy. The latter mediated intervention effects on physical activity and reduced sugared drink consumption. In conclusion, our MI intervention was successful in increasing task self-efficacy, which was related to improved health behaviours.