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Effect of a family and interdisciplinary intervention to prevent T2D: randomized clinical trial.
Vargas-Ortiz, K, Lira-Mendiola, G, Gómez-Navarro, CM, Padilla-Estrada, K, Angulo-Romero, F, Hernández-Márquez, JM, Villa-Martínez, AK, González-Mena, JN, Macías-Cervantes, MH, Reyes-Escogido, ML, et al
BMC public health. 2020;20(1):97
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In individuals at high risk of type 2 diabetes, lifestyle interventions rather than medication have been more successful in preventing development of the disease, however the benefits of lifestyle strategies diminishes over time due to possible adherence issues. Prolonged lifestyle changes may be affected by lack of family support, but research on family support during lifestyle changes in individuals prior to diabetes is lacking. This parallel randomised control trial of 122 patients with prediabetes and 101 of their family members aimed to assess the impact of family supported diet and exercise changes compared to self-motivation on individuals with prediabetes. At 6 months, body measurements and markers of prediabetes improved in both groups. Lipids were significantly improved in the group with family support compared to having no support. At 12 months there were a high number of dropouts due to lack of patient interest. Benefits shown at 6 months in both groups were only maintained or improved upon with family support and the lipid profile of the individual intervention group actually worsened in comparison to when participants entered the trial. After 12 months the incidence rate of type 2 diabetes was similar in both groups. Individuals with prediabetes who had family support whilst undergoing a diet and exercise regime were more successful at maintaining improvements of factors contributing to diabetes, compared to individuals without support. However this did not affect the occurrence of type 2 diabetes. Clinicians could use this paper to communicate the importance of family support during lifestyle changes in patients at high risk of developing type 2 diabetes, although close monitoring may be required to ensure compliance.
Abstract
BACKGROUND Lifestyle changes can reduce the risk of T2D; however, no study has evaluated the effect of a lifestyle intervention involving patients´ family. The aim of this study was to compare the impact of an interdisciplinary family (FI) Vs individual intervention (II) on glucose metabolism, insulin resistance (IR), pancreatic β-cell function and cardiovascular risk markers in patients with prediabetes, as well as to measure the impact on their families' metabolic risk. METHODS Randomized Clinical Trial (RCT) to compare the impact of FI and II on IR and pancreatic β-cell function in subjects with prediabetes. There were 122 subjects with prediabetes (and 101 family members) randomized to FI or II. Data were collected in 2015-2016 and analyzed in 2017-2018. FI group had the support of their family members, who also received personalized diet and exercise recommendations; patients and their family members attended monthly a lifestyle enhancement program. II group received personalized diet and exercise recommendations. The follow-up was for 12 months. Glucose, IR, pancreatic β-cell function and secondary outcomes (body composition and lipid profile) were assessed at baseline, 6 and 12 months. RESULTS FI group improved area under the glucose curve (AUC) (from 18,597 ± 2611 to 17,237 ± 2792, p = 0.004) and the Matsuda index (from 3.5 ± 2.3 to 4.7 ± 3.5, p = 0.05) at 12 months. II group improved Disposition Index (from 1.5 ± 0.4 to 1.9 ± 0.73, p < .0001) at 12 months. The improvements achieved in weight and lipids at 6 months, were lost in II group at 12 moths, whereas in FI persisted. Adherence up to 12 months was not different between the study groups (FI 56% Vs II 60%). CONCLUSIONS FI intervention was more effective by improving glucose AUC, insulin sensitivity and lipid profile, besides that, metabolic risk in family members of the FI group was maintained, while the risk of II group was increased. TRIAL REGISTRATION This study was retrospectively registered at clinicaltrials.gov on December 15, 2015 (NTC026365646).
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Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial.
Daumit, GL, Dalcin, AT, Dickerson, FB, Miller, ER, Evins, AE, Cather, C, Jerome, GJ, Young, DR, Charleston, JB, Gennusa, JV, et al
JAMA network open. 2020;3(6):e207247
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Heart disease death rates in individuals with serious mental illness are double that of the general population, indicating a concerted effort is needed to help this group of people. However, previous studies on interventions have failed to show improvements indicating a requirement to identify effective solutions. This randomised control trial of 269 individuals with mental illness aimed to determine the effectiveness of an 18-month management plan to reduce heart disease risk. The results showed that heart disease risk was significantly decreased when individuals with mental illness were in a closely monitored management programme. This programme consisted of behavioural counselling and care coordination. It was concluded that a multi-faceted care management plan can significantly reduce the risk of heart disease in individuals with serious mental illness. This study could be used by health care professionals to understand that individuals with mental illness are at a higher risk of death from heart disease and that they need to consider enrolling them into a closely monitored management plan.
Abstract
Importance: Persons with serious mental illness have a cardiovascular disease mortality rate more than twice that of the overall population. Meaningful cardiovascular risk reduction requires targeted efforts in this population, who often have psychiatric symptoms and cognitive impairment. Objective: To determine the effectiveness of an 18-month multifaceted intervention incorporating behavioral counseling, care coordination, and care management for overall cardiovascular risk reduction in adults with serious mental illness. Design, Setting, and Participants: This randomized clinical trial was conducted from December 2013 to November 2018 at 4 community mental health outpatient programs in Maryland. The study recruited adults with at least 1 cardiovascular disease risk factor (hypertension, diabetes, dyslipidemia, current tobacco smoking, and/or overweight or obesity) attending the mental health programs. Of 398 participants screened, 269 were randomized to intervention (132 participants) or control (137 participants). Data collection staff were blinded to group assignment. Data were analyzed on the principle of intention to treat, and data analysis was performed from November 2018 to March 2019. Interventions: A health coach and nurse provided individually tailored cardiovascular disease risk reduction behavioral counseling, collaborated with physicians to implement appropriate risk factor management, and coordinated with mental health staff to encourage attainment of health goals. Programs offered physical activity classes and received consultation on serving healthier meals; intervention and control participants were exposed to these environmental changes. Main Outcomes and Measures: The primary outcome was the change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), which estimates the 10-year probability of a cardiovascular disease event, from baseline to 18 months, expressed as percentage change for intervention compared with control. Results: Of 269 participants randomized (mean [SD] age, 48.8 [11.9] years; 128 men [47.6%]), 159 (59.1%) had a diagnosis of schizophrenia or schizoaffective disorder, 67 (24.9%) had bipolar disorder, and 38 (14.1%) had major depressive disorder. At 18 months, the primary outcome, FRS, was obtained for 256 participants (95.2%). The mean (SD) baseline FRS was 11.5% (11.5%) (median, 8.6%; interquartile range, 3.9%-16.0%) in the intervention group and 12.7% (12.7%) (median, 9.1%; interquartile range, 4.0%-16.7%) in the control group. At 18 months, the mean (SD) FRS was 9.9% (10.2%) (median, 7.7%; interquartile range, 3.1%-12.0%) in the intervention group and 12.3% (12.0%) (median, 9.7%; interquartile range, 4.0%-15.9%) in the control group. Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months. Conclusions and Relevance: An 18-month behavioral counseling, care coordination, and care management intervention statistically significantly reduced overall cardiovascular disease risk in adults with serious mental illness. This intervention provides the means to substantially reduce health disparities in this high-risk population. Trial Registration: ClinicalTrials.gov Identifier: NCT02127671.
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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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Predictors of completing a primary health care diabetes prevention intervention programme in people at high risk of type 2 diabetes: Experiences of the DE-PLAN project.
Gilis-Januszewska, A, Lindström, J, Barengo, NC, Tuomilehto, J, Schwarz, PE, Wójtowicz, E, Piwońska-Solska, B, Szybiński, Z, Windak, A, Hubalewska-Dydejczyk, A
Medicine. 2018;97(5):e9790
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As the prevalence of type 2 diabetes (T2D) begins to grow, the spotlight is on successful, cost-effective lifestyle interventions to help prevent it. Real-life implementation studies in various settings and with various people have shown than lower cost, less intensive interventions can help prevent T2D. The DE-PLAN (Diabetes in Europe: Prevention Using Lifestyle, Physical Activity and Nutritional Intervention) was implemented across 17 European countries, where it aimed to assess its application but also to create a network of trained professionals to deliver T2D prevention. This study aimed to explore the factors associated with completing the programme in primary healthcare in Poland. The study included nine GP practices in Krakow with 262 people at high risk of T2D (according to the Finnish Diabetes Risk Score). The prevention programme included 11 lifestyle counselling sessions, physical activity sessions and motivational phone calls/letters. Measurements including fasting glucose, body mass index and blood pressure were taken at baseline and 1 year after the programme. People who completed the whole programme were less likely to be employed, less likely to have high blood pressure and ate more fruits and vegetables each day. The authors concluded that people who healthier behaviours were more likely to complete the programme, whereas men and people who work were less likely to complete the programme. More strategies are needed to increase completion with these individuals.
Abstract
It has been shown that real-life implementation studies for the prevention of type 2 diabetes (DM2) performed in different settings and populations can be effective. However, not enough information is available on factors influencing the reach of DM2 prevention programmes. This study examines the predictors of completing an intervention programme targeted at people at high risk of DM2 in Krakow, Poland as part of the DE-PLAN project.A total of 262 middle-aged people, everyday patients of 9 general practitioners' (GP) practices, at high risk of DM2 (Finnish Diabetes Risk Score (FINDRISK) >14) agreed to participate in the lifestyle intervention to prevent DM2. Intervention consisted of 11 lifestyle counseling sessions, organized physical activity sessions followed by motivational phone calls and letters. Measurements were performed at baseline and 1 year after the initiation of the intervention.Seventy percent of the study participants enrolled completed the core curriculum (n = 184), 22% were men. When compared to noncompleters, completers had a healthier baseline diabetes risk profile (P <.05). People who completed the intervention were less frequently employed versus noncompleters (P = .037), less often had hypertension (P = .043), and more frequently consumed vegetables and fruit daily (P = .055).In multiple logistic regression model, employment reduced the likelihood of completing the intervention 2 times (odds ratio [OR] 0.45, 95% confidence interval [CI] 0.25-0.81). Higher glucose 2 hours after glucose load and hypertension were the independent factors decreasing the chance to participate in the intervention (OR 0.79, 95% 0.69-0.92 and OR 0.52, 95% CI 0.27-0.99, respectively). Daily consumption of vegetables and fruits increased the likelihood of completing the intervention (OR 1.86, 95% 1.01-3.41).In conclusion, people with healthier behavior and risk profile are more predisposed to complete diabetes prevention interventions. Male, those who work and those with a worse health profile, are less likely to participate and complete interventions. Targeted strategies are needed in real-life diabetes prevention interventions to improve male participation and to reach those who are working as well as people with a higher risk profile.
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Impact of probiotic Saccharomyces boulardii on the gut microbiome composition in HIV-treated patients: A double-blind, randomised, placebo-controlled trial.
Villar-García, J, Güerri-Fernández, R, Moya, A, González, A, Hernández, JJ, Lerma, E, Guelar, A, Sorli, L, Horcajada, JP, Artacho, A, et al
PloS one. 2017;12(4):e0173802
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Recent studies have shown that HIV severely damages the gastrointestinal (GI) mucosal barrier, resulting in microbes passing from the GI tract to the circulatory system leading to chronic inflammation. The aim of this randomised double blind study was to analyse the beneficial effects of probiotic supplementation on the gut microbiome composition. 44 chronic HIV infected patients were treated with 12 weeks of specific strain of probiotic called Saccharomyces Boulardii. The authors found that supplementation with the probiotic changed the composition of gut microbiome, with a decrease in pathogenic bacteria observed in the study group. However, no correlation could be established with regard to inflammation. The authors concluded that identifying the pro inflammatory species in the gut can be the markers of poor immune response.
Abstract
Dysbalance in gut microbiota has been linked to increased microbial translocation, leading to chronic inflammation in HIV-patients, even under effective HAART. Moreover, microbial translocation is associated with insufficient reconstitution of CD4+T cells, and contributes to the pathogenesis of immunologic non-response. In a double-blind, randomised, placebo-controlled trial, we recently showed that, compared to placebo, 12 weeks treatment with probiotic Saccharomyces boulardii significantly reduced plasma levels of bacterial translocation (Lipopolysaccharide-binding protein or LBP) and systemic inflammation (IL-6) in 44 HIV virologically suppressed patients, half of whom (n = 22) had immunologic non-response to antiretroviral therapy (<270 CD4+Tcells/μL despite long-term suppressed viral load). The aim of the present study was to investigate if this beneficial effect of the probiotic Saccharomyces boulardii is due to modified gut microbiome composition, with a decrease of some species associated with higher systemic levels of microbial translocation and inflammation. In this study, we used 16S rDNA gene amplification and parallel sequencing to analyze the probiotic impact on the composition of the gut microbiome (faecal samples) in these 44 patients randomized to receive oral supplementation with probiotic or placebo for 12 weeks. Compared to the placebo group, in individuals treated with probiotic we observed lower concentrations of some gut species, such as those of the Clostridiaceae family, which were correlated with systemic levels of bacterial translocation and inflammation markers. In a sub-study of these patients, we observed significantly higher parameters of microbial translocation (LBP, soluble CD14) and systemic inflammation in immunologic non-responders than in immunologic responders, which was correlated with a relative abundance of specific gut bacterial groups (Lachnospiraceae genus and Proteobacteria). Thus, in this work, we propose a new therapeutic strategy using the probiotic yeast S. boulardii to modify gut microbiome composition. Identifying pro-inflammatory species in the gut microbiome could also be a useful new marker of poor immune response and a new therapeutic target.
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Exercise as adjunctive treatment for alcohol use disorder: A randomized controlled trial.
Roessler, KK, Bilberg, R, Søgaard Nielsen, A, Jensen, K, Ekstrøm, CT, Sari, S
PloS one. 2017;12(10):e0186076
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Treating alcohol-use disorder (AUD) is challenging and multi-faceted thus many analyses suggest the effectiveness of interventions be low. Recent evidence suggests exercise may be a promising addition to intervention in both reducing consumption as well as the co-morbidities linked with AUD. The aim of this study was to evaluate the efficacy of physical activity as an adjunct to outpatient alcohol treatment on alcohol consumption in 100 patients. Participants were allocated to one of three arms: treatment, treatment with group exercise or treatment with individual exercise, and alcohol intake was measured at six and 12 months after treatment initiation. This study demonstrated that there is no significant effect of physical activity on alcohol consumption, however moderate physical activity was seen to be protective against excessive drinking following treatment. Based on this study as well as the Health Lifestyle Study, the authors support the need for implementing physically active lifestyles for patients in treatment.
Abstract
AIMS: To examine whether physical activity as an adjunct to outpatient alcohol treatment has an effect on alcohol consumption following participation in an exercise intervention of six months' duration, and at 12 months after treatment initiation. METHODS The study is a randomized controlled study with three arms: Patients allocated to (A) treatment as usual, (B) treatment as usual and supervised group exercise, (C) treatment as usual and individual physical exercise. The primary outcome measure was excessive drinking six months after treatment start and completion of the intervention. A logistic regression model was used to evaluate the odds of excessive drinking among the three groups, based on intention-to-treat. Changes in level of physical activity in all three groups were tested by using a generalized linear mixed model. A multiple linear model was used to test if there was an association between amount of performed physical activity and alcohol consumption. RESULTS A total of 175 patients (68.6% male) participated. Response rates were 77.7% at six months and 57.1% at 12 months follow-up. OR 0.99 [95% CI: 0.46; 2.14], p = 0.976 for excessive drinking in the group exercise condition, and 1.02 [95% CI: 0.47; 2.18], p = 0.968 in the individual exercise condition, which, when compared to the control group as reference, did not differ statistically significantly. Participants with moderate level physical activity had lower odds for excessive drinking OR = 0.12 [0.05; 0.31], p<0.001 than participants with low level physical activity. Amount of alcohol consumption in the intervention groups decreased by 4% [95% CI: 0.03; 6.8], p = 0.015 for each increased exercising day. CONCLUSIONS No direct effect of physical exercise on drinking outcome was found. Moderate level physical activity was protective against excessive drinking following treatment. A dose-response effect of exercise on drinking outcome supports the need for implementing physically active lifestyles for patients in treatment for alcohol use disorder.