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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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A Mediterranean-style dietary intervention supplemented with fish oil improves diet quality and mental health in people with depression: A randomized controlled trial (HELFIMED).
Parletta, N, Zarnowiecki, D, Cho, J, Wilson, A, Bogomolova, S, Villani, A, Itsiopoulos, C, Niyonsenga, T, Blunden, S, Meyer, B, et al
Nutritional neuroscience. 2019;22(7):474-487
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Observational studies have shown that a healthy diet is associated with a reduced risk for depression. This study investigated whether a Mediterranean-style diet supplemented with fish oil can improve mental health in adults suffering depression. Adults with self-reported depression were randomised to receive fortnightly food hampers and Mediterranean diet cooking workshops for 3 months and fish oil supplements for 6 months, or attend social groups fortnightly for 3 months. Assessments at baseline, 3 and 6 months included mental health, quality of life and dietary questionnaires, and blood samples for fatty acid analysis. Both groups experienced in improvements in their mental health. The Mediterranean diet group had greater reduction in depression and improved mental health quality of life scores at 3 months and 6 months. Reduced depression was correlated with an increased Mediterranean diet score, nuts and vegetable diversity. Other mental health improvements were associated with increased vegetable diversity and legumes. There were some correlations between increased omega-3, decreased omega-6 and improved mental health. The authors suggest that getting back to basics by promoting cooking skills and family/group meals could be a simple yet powerful and empowering approach to healthcare and prevention.
Abstract
OBJECTIVES We investigated whether a Mediterranean-style diet (MedDiet) supplemented with fish oil can improve mental health in adults suffering depression. METHODS Adults with self-reported depression were randomized to receive fortnightly food hampers and MedDiet cooking workshops for 3 months and fish oil supplements for 6 months, or attend social groups fortnightly for 3 months. Assessments at baseline, 3 and 6 months included mental health, quality of life (QoL) and dietary questionnaires, and blood samples for erythrocyte fatty acid analysis. RESULTS n = 152 eligible adults aged 18-65 were recruited (n = 95 completed 3-month and n = 85 completed 6-month assessments). At 3 months, the MedDiet group had a higher MedDiet score (t = 3.95, P < 0.01), consumed more vegetables (t = 3.95, P < 0.01), fruit (t = 2.10, P = 0.04), nuts (t = 2.29, P = 0.02), legumes (t = 2.41, P = 0.02) wholegrains (t = 2.63, P = 0.01), and vegetable diversity (t = 3.27, P < 0.01); less unhealthy snacks (t = -2.10, P = 0.04) and red meat/chicken (t = -2.13, P = 0.04). The MedDiet group had greater reduction in depression (t = -2.24, P = 0.03) and improved mental health QoL scores (t = 2.10, P = 0.04) at 3 months. Improved diet and mental health were sustained at 6 months. Reduced depression was correlated with an increased MedDiet score (r = -0.298, P = 0.01), nuts (r = -0.264, P = 0.01), and vegetable diversity (r = -0.303, P = 0.01). Other mental health improvements had similar correlations, most notably for increased vegetable diversity and legumes. There were some correlations between increased omega-3, decreased omega-6 and improved mental health. DISCUSSION This is one of the first randomized controlled trials to show that healthy dietary changes are achievable and, supplemented with fish oil, can improve mental health in people with depression.
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Time and Intervention Effects of Daily Almond Intake on the Changes of Lipid Profile and Body Composition Among Free-Living Healthy Adults.
Liu, Y, Hwang, HJ, Kim, HS, Park, H
Journal of medicinal food. 2018;21(4):340-347
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Existing evidence shows that tree nut intake may reduce risk factors associated cardiovascular diseases. While studies have demonstrated this with almond consumption, the mechanism remains uncertain. The aim of this randomised controlled trial was to evaluate the effects of daily almond consumption on changes in body composition and lipid profiles at four different measurement points to provide further mechanistic insight. Eighty-five participants were randomised to either almond or control group and those in the almond group consumed 56g of almonds per day for 20 weeks. Anthropometric and bioimpedance measures were taken, as well as blood lipid profiles, at weeks 0, 8, 16 and 20. This study revealed patterns in blood lipid profiles fluctuations throughout the 20 weeks by utilising four time points. Continuous almond consumption led to significantly greater reductions in blood lipid levels compared to the control group, demonstrating the cardioprotective effects of almonds.
Abstract
Favorable health benefits of almond have been shown in several previous studies. However, repeated measures, randomized, controlled trials to investigate the changes due to almond intake based on the time effects have not yet been reported. The current study was conducted to evaluate the effects of daily almond intake on changes in body composition and lipid profiles for 20 weeks with four measurements among healthy adults. Participants in the almond group showed favorable changes on blood lipid profiles, including levels of triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and non-high-density lipoprotein (non-HDL-C) after consuming 56 g of almond per day for 20 weeks compared with those at baseline. At week 20, subjects in the almond group showed significantly decreased TC, LDL-C, non-HDL-C, TG, body fat mass, and waist-hip ratio compared with those of the control group who consumed isocaloric control food. The mixed model also confirmed that there were significant time effects in several bioimpedance indicators (i.e., total body protein, fat-free mass, etc.) and all of the lipid profile parameters in the almond group. These results confirm the effects of lipid-lowering and modifying body composition of almond consumption. In addition, our results suggest that the measuring time points would be critical to capture the effects of dietary intervention.
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Mediterranean Diet and Age-Related Cognitive Decline: A Randomized Clinical Trial.
Valls-Pedret, C, Sala-Vila, A, Serra-Mir, M, Corella, D, de la Torre, R, Martínez-González, MÁ, Martínez-Lapiscina, EH, Fitó, M, Pérez-Heras, A, Salas-Salvadó, J, et al
JAMA internal medicine. 2015;175(7):1094-1103
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There is increasing evidence associating dietary habits and cognitive function, and oxidative stress is known to play a major role in cognitive decline. The Mediterranean diet is a plant-based, antioxidant rich dietary pattern and large observational studies have elucidated that Mediterranean diet adherence is associated with better cognitive function. The aim of this study was to investigate whether a Mediterranean diet supplemented with antioxidant-rich foods influences cognitive function compared with a control diet. Participants were randomly assigned to a Mediterranean diet supplemented with extra virgin olive oil, a Mediterranean diet supplemented with mixed nuts or a control diet with dietary advice. The study included 447 cognitively healthy volunteers at high cardiovascular risk and rates of cognitive change were followed for an average of four years. According to the findings of this study, a long-term Mediterranean diet supplemented with olive oil or nuts is associated with improved cognitive function and may counteract age-related cognitive decline. It is hypothesised that this effect is attributed to the abundance of antioxidants and anti-inflammatory agents of the Mediterranean diet and may contribute to effective interventions to prevent or delay the onset of cognitive decline.
Abstract
IMPORTANCE Oxidative stress and vascular impairment are believed to partly mediate age-related cognitive decline, a strong risk factor for development of dementia. Epidemiologic studies suggest that a Mediterranean diet, an antioxidant-rich cardioprotective dietary pattern, delays cognitive decline, but clinical trial evidence is lacking. OBJECTIVE To investigate whether a Mediterranean diet supplemented with antioxidant-rich foods influences cognitive function compared with a control diet. DESIGN, SETTING, AND PARTICIPANTS Parallel-group randomized clinical trial of 447 cognitively healthy volunteers from Barcelona, Spain (233 women [52.1%]; mean age, 66.9 years), at high cardiovascular risk were enrolled into the Prevención con Dieta Mediterránea nutrition intervention trial from October 1, 2003, through December 31, 2009. All patients underwent neuropsychological assessment at inclusion and were offered retesting at the end of the study. INTERVENTIONS Participants were randomly assigned to a Mediterranean diet supplemented with extravirgin olive oil (1 L/wk), a Mediterranean diet supplemented with mixed nuts (30 g/d), or a control diet (advice to reduce dietary fat). MAIN OUTCOMES AND MEASURES Rates of cognitive change over time based on a neuropsychological test battery: Mini-Mental State Examination, Rey Auditory Verbal Learning Test (RAVLT), Animals Semantic Fluency, Digit Span subtest from the Wechsler Adult Intelligence Scale, Verbal Paired Associates from the Wechsler Memory Scale, and the Color Trail Test. We used mean z scores of change in each test to construct 3 cognitive composites: memory, frontal (attention and executive function), and global. RESULTS Follow-up cognitive tests were available in 334 participants after intervention (median, 4.1 years). In multivariate analyses adjusted for confounders, participants allocated to a Mediterranean diet plus olive oil scored better on the RAVLT (P = .049) and Color Trail Test part 2 (P = .04) compared with controls; no between-group differences were observed for the other cognitive tests. Similarly adjusted cognitive composites (mean z scores with 95% CIs) for changes above baseline of the memory composite were 0.04 (-0.09 to 0.18) for the Mediterranean diet plus olive oil, 0.09 (-0.05 to 0.23; P = .04 vs controls) for the Mediterranean diet plus nuts, and -0.17 (-0.32 to -0.01) for the control diet. Respective changes from baseline of the frontal cognition composite were 0.23 (0.03 to 0.43; P = .003 vs controls), 0.03 (-0.25 to 0.31), and -0.33 (-0.57 to -0.09). Changes from baseline of the global cognition composite were 0.05 (-0.11 to 0.21; P = .005 vs controls) for the Mediterranean diet plus olive oil, -0.05 (-0.27 to 0.18) for the Mediterranean diet plus nuts, and -0.38 (-0.57 to -0.18) for the control diet. All cognitive composites significantly (P < .05) decreased from baseline in controls. CONCLUSIONS AND RELEVANCE In an older population, a Mediterranean diet supplemented with olive oil or nuts is associated with improved cognitive function. TRIAL REGISTRATION isrctn.org Identifier: ISRCTN35739639.