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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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Use of Novel High-Protein Functional Food Products as Part of a Calorie-Restricted Diet to Reduce Insulin Resistance and Increase Lean Body Mass in Adults: A Randomized Controlled Trial.
Johnston, CS, Sears, B, Perry, M, Knurick, JR
Nutrients. 2017;9(11)
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Reducing insulin resistance (IR) is achieved by either calorie restriction or increase of lean muscle mass, however calorie restriction tends to lead to a decrease of lean mass. The aim of this trial was to determine whether the protein content of a low-calorie diet impacted insulin resistance levels. Twenty-one healthy adults at risk of IR were randomly assigned to receive either high-protein diet or conventional diet food packages, both of which had the same calorie restriction. Weight and blood samples were collected at baseline and six weeks. This study found that an increased protein consumption with moderate calorie restriction was 140% more effective for reducing IR compared to a conventional, isocaloric diet. While significant weight loss occurred in both groups, the reduction in IR was significantly associated only with the increase of lean mass. These results justify future long-term studies focusing on the combination of various dietary strategies to reduce IR and increase lean mass.
Abstract
Significant reductions in insulin resistance (IR) can be achieved by either calorie restriction or by the increase of lean mass. However, calorie restriction usually results in significant loss of lean mass. A 6-week randomized controlled feeding trial was conducted to determine if a calorie-restricted, high-protein diet (~125 g protein/day consumed evenly throughout the day) using novel functional foods would be more successful for reducing IR in comparison to a conventional diet (~80 g protein/day) with a similar level of calorie restriction. Healthy adults (age 20-75 years; body mass index, 20-42 kg/m²) with raised triglyceride/high-density lipoprotein ratios were randomly assigned to the control group (CON: test foods prepared using gluten-free commercial pasta and cereal) or to the high-protein group (HPR: test foods prepared using novel high-protein pasta and cereal both rich in wheat gluten). Mean weight loss did not differ between groups (-2.7 ± 2.6 and -3.2 ± 3.0 kg for CON (n = 11) and HPR (n = 10) respectively, p = 0.801); however, the 6-week change in fat-free mass (FFM) differed significantly between groups (-0.5 ± 1.5 and +1.5 ± 3.8 kg for CON and HPR respectively, p = 0.008). IR improved in HPR vs. CON participants (homeostasis model assessment-estimated insulin resistance [HOMAIR] change: -1.7 ± 1.4 and -0.7 ± 0.7 respectively; p = 0.020). The change in HOMA-IR was related to the change in FFM among participants (r = -0.511, p = 0.021). Thus, a high-protein diet using novel functional foods combined with modest calorie restriction was 140% more effective for reducing HOMA-IR in healthy adults compared to a lower protein, standard diet with an equal level of calorie restriction.