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Adherence to Mediterranean Diet and NAFLD in Patients with Metabolic Syndrome: The FLIPAN Study.
Montemayor, S, Mascaró, CM, Ugarriza, L, Casares, M, Llompart, I, Abete, I, Zulet, MÁ, Martínez, JA, Tur, JA, Bouzas, C
Nutrients. 2022;14(15)
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Non-alcoholic fatty liver disease (NAFLD) is characterised by fat deposition that is not linked to excessive alcohol intake. This condition is often linked to other health issues such as obesity, metabolic syndrome, type 2 diabetes and cardiovascular disease, and they share common diagnostic biomarkers. An unhealthy diet and lifestyle are also linked to the progression of NAFLD. Mediterranean diet is a predominantly plant-based diet that may have an association with lower risk and reduced severity of NAFLD. This multicentre, prospective, randomised controlled trial included one hundred and thirty-six NAFLD patients to analyse the effect of Mediterranean diet adherence on NAFLD in patients with metabolic syndrome. The NAFLD patients followed a personalised Mediterranean diet and physical activity interventions for six months. Individuals with greater adherence to the Mediterranean diet and physical activity interventions showed improvements in body mass index, body weight, waist circumference, blood pressure and intrahepatic fat content after six months of intervention. Healthcare professionals can use the results of this study to understand the benefits of adherence to the Mediterranean diet and physical activity interventions in reducing NAFLD severity and metabolic irregularities. However, due to the small sample size of this study, further robust studies are required to evaluate the benefits of different dietary strategies, the therapeutic value of different food items and the intervention duration required to achieve improvements in NAFLD and metabolic syndrome.
Abstract
Unhealthy diet is an important factor in the progression of non-alcoholic fatty liver disease (NAFLD). Previous studies showed the benefits of a Mediterranean diet (MedDiet) on Metabolic syndrome (MetS), type 2 diabetes mellitus (T2DM), and cardiovascular diseases, which usually have a pathophysiological relationship with NAFLD. To assess the effect of adherence to a MedDiet on NAFLD in MetS patients after lifestyle intervention, this multicentre (Mallorca and Navarra, Spain) prospective randomized trial, with personalized nutritional intervention based on a customized MedDiet, coupled with physical activity promotion was performed to prevent, and reverse NAFLD among patients with MetS. The current analysis included 138 patients aged 40 to 60 years old, Body Mass Index (BMI) 27-40 kg/m2, diagnosed with NAFLD using MRI, and MetS according to the International Diabetes Federation (IDF). A validated food frequency questionnaire was used to assess dietary intake. Adherence to Mediterranean diet by means of a 17-item validated questionnaire, anthropometrics, physical activity, blood pressure, blood biochemical parameters, and intrahepatic fat contents (IFC) were measured. The independent variable used was changes in MedDiet adherence, categorized in tertiles after 6 months follow-up. Subjects with high adherence to the MedDiet showed higher decreases in BMI, body weight, WC, SBP, DBP, and IFC. An association between improvement in adherence to the MedDiet and amelioration of IFC after 6-month follow-up was observed. High adherence to the MedDiet is associated with better status of MetS features, and better values of IFC.
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Association of Major Dietary Protein Sources With All-Cause and Cause-Specific Mortality: Prospective Cohort Study.
Sun, Y, Liu, B, Snetselaar, LG, Wallace, RB, Shadyab, AH, Kroenke, CH, Haring, B, Howard, BV, Shikany, JM, Valdiviezo, C, et al
Journal of the American Heart Association. 2021;10(5):e015553
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Dietary recommendations for human health focusing on total protein intake without considering specific protein sources may be simplistic and insufficient. The aim of this study was to investigate whether different dietary protein sources would be differentially associated with mortality risk. The study is based on data from a large prospective cohort study with up to 18-years of follow-up to investigate the risks of all-cause and cause-specific mortality in relation to animal and plant protein intake, and major sources of dietary protein. Results indicate that intake of plant protein and substitution of animal protein with plant protein, were associated with lower risk of all-cause, cardiovascular disease, and dementia mortality. Furthermore, substitution of red meat, eggs, dairy products, or legumes with nuts was associated with lower risk of all-cause mortality. Authors conclude that their findings support the need for consideration of protein sources, in addition to the amount of protein intake, in future dietary guidelines.
Abstract
Background Dietary recommendations regarding protein intake have been focused on the amount of protein. However, such recommendations without considering specific protein sources may be simplistic and insufficient. Methods and Results We included 102 521 postmenopausal women enrolled in the Women's Health Initiative between 1993 and 1998, and followed them through February 2017. During 1 876 205 person-years of follow-up, 25 976 deaths occurred. Comparing the highest with the lowest quintile, plant protein intake was inversely associated with all-cause mortality (hazard ratio [HR], 0.91 [0.86, 0.96]), cardiovascular disease mortality (HR, 0.88 [0.79, 0.97]), and dementia mortality (HR, 0.79 [0.67, 0.94]). Among major protein sources, comparing the highest with the lowest quintile of consumption, processed red meat (HR, 1.06 [1.01, 1.10]) or eggs (HR, 1.14 [1.10, 1.19]) was associated with higher risk of all-cause mortality. Unprocessed red meat (HR, 1.12 [1.02, 1.23]), eggs (HR, 1.24 [1.14, 1.34]), or dairy products (HR, 1.11 [1.02, 1.22]) was associated with higher risk of cardiovascular disease mortality. Egg consumption was associated with higher risk of cancer mortality (HR, 1.10 [1.02, 1.19]). Processed red meat consumption was associated with higher risk of dementia mortality (HR, 1.20 [1.05, 1.32]), while consumption of poultry (HR, 0.85 [0.75, 0.97]) or eggs (HR, 0.86 [0.75, 0.98]) was associated with lower risk of dementia mortality. In substitution analysis, substituting of animal protein with plant protein was associated with a lower risk of all-cause mortality, cardiovascular disease mortality, and dementia mortality, and substitution of total red meat, eggs, or dairy products with nuts was associated with a lower risk of all-cause mortality. Conclusions Different dietary protein sources have varying associations with all-cause mortality, cardiovascular disease mortality, and dementia mortality. Our findings support the need for consideration of protein sources in future dietary guidelines.
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Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity Advice on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial.
Mueller, S, Winzer, EB, Duvinage, A, Gevaert, AB, Edelmann, F, Haller, B, Pieske-Kraigher, E, Beckers, P, Bobenko, A, Hommel, J, et al
JAMA. 2021;325(6):542-551
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Heart failure with preserved ejection fraction (HFpEF) is a condition in which the heart's lower left chamber is less able to pump blood due to stiffness. The prevalence of HFpEF is high among the elderly. Endurance exercise is known to increase peak oxygen consumption (Vo2). This prospective, randomised, controlled, three-armed, multi-centre trial aimed to understand the effects of endurance training in older people with HFpEF at 3 and 12 months. In this study, 180 sedentary patients with HFpEF were randomly assigned to high-intensity interval training, moderate continuous training, or control of home-based tele-guideline physical activity advice. The study found no statistically significant difference in changes in V̇o2 between high-intensity interval and moderate continuous training, and neither group met the clinically significant difference of 2.5 mL/kg/min compared with the guideline control. Diastolic function or natriuretic peptides did not change significantly in any group. Adherence level was lower among elderly patients, and there were serious adverse effects in patients with HFpEE. Healthcare professionals can use the findings of this study to understand the impact and adverse effects of endurance training at different intensities in patients with HFpEE.
Abstract
Importance: Endurance exercise is effective in improving peak oxygen consumption (peak V̇o2) in patients with heart failure with preserved ejection fraction (HFpEF). However, it remains unknown whether differing modes of exercise have different effects. Objective: To determine whether high-intensity interval training, moderate continuous training, and guideline-based advice on physical activity have different effects on change in peak V̇o2 in patients with HFpEF. Design, Setting, and Participants: Randomized clinical trial at 5 sites (Berlin, Leipzig, and Munich, Germany; Antwerp, Belgium; and Trondheim, Norway) from July 2014 to September 2018. From 532 screened patients, 180 sedentary patients with chronic, stable HFpEF were enrolled. Outcomes were analyzed by core laboratories blinded to treatment groups; however, the patients and staff conducting the evaluations were not blinded. Interventions: Patients were randomly assigned (1:1:1; n = 60 per group) to high-intensity interval training (3 × 38 minutes/week), moderate continuous training (5 × 40 minutes/week), or guideline control (1-time advice on physical activity according to guidelines) for 12 months (3 months in clinic followed by 9 months telemedically supervised home-based exercise). Main Outcomes and Measures: Primary end point was change in peak V̇o2 after 3 months, with the minimal clinically important difference set at 2.5 mL/kg/min. Secondary end points included changes in metrics of cardiorespiratory fitness, diastolic function, and natriuretic peptides after 3 and 12 months. Results: Among 180 patients who were randomized (mean age, 70 years; 120 women [67%]), 166 (92%) and 154 (86%) completed evaluation at 3 and 12 months, respectively. Change in peak V̇o2 over 3 months for high-intensity interval training vs guideline control was 1.1 vs -0.6 mL/kg/min (difference, 1.5 [95% CI, 0.4 to 2.7]); for moderate continuous training vs guideline control, 1.6 vs -0.6 mL/kg/min (difference, 2.0 [95% CI, 0.9 to 3.1]); and for high-intensity interval training vs moderate continuous training, 1.1 vs 1.6 mL/kg/min (difference, -0.4 [95% CI, -1.4 to 0.6]). No comparisons were statistically significant after 12 months. There were no significant changes in diastolic function or natriuretic peptides. Acute coronary syndrome was recorded in 4 high-intensity interval training patients (7%), 3 moderate continuous training patients (5%), and 5 guideline control patients (8%). Conclusions and Relevance: Among patients with HFpEF, there was no statistically significant difference in change in peak V̇o2 at 3 months between those assigned to high-intensity interval vs moderate continuous training, and neither group met the prespecified minimal clinically important difference compared with the guideline control. These findings do not support either high-intensity interval training or moderate continuous training compared with guideline-based physical activity for patients with HFpEF. Trial Registration: ClinicalTrials.gov Identifier: NCT02078947.
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Usefulness of a Lifestyle Intervention in Patients With Cardiovascular Disease.
Broers, ER, Gavidia, G, Wetzels, M, Ribas, V, Ayoola, I, Piera-Jimenez, J, Widdershoven, JWMG, Habibović, M
The American journal of cardiology. 2020;125(3):370-375
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Modifiable (behavioural) risk factors such as sedentary lifestyle and low sleep efficiency, are associated with increased mortality risk and disease progression in individuals with cardiovascular disease. The main aim of this study was to evaluate changes in objectively measured lifestyle and health data derived from wearable devices. This study was part of an international, multicenter randomized controlled trial, the Do Cardiac Health Advanced New Generation Ecosystem 2 study. Only the participants (n=70) randomised to the intervention group were analysed. The participants received the devices to monitor their lifestyle and health parameters. Results indicate significant changes over time in the number of steps and activity level. No significant improvement over time was observed in other outcome measures (i.e., blood pressure, weight, and sleep efficiency). Secondary analysis showed demographic (gender, nationality, marital status), clinical (co-morbidities, heart failure), and psychological (anxiety, depression) profiles that were associated with lifestyle measures. Authors conclude that a personalised approach might be the way forward in order to improve health outcomes in the future.
Abstract
The importance of modifying lifestyle factors in order to improve prognosis in cardiac patients is well-known. Current study aims to evaluate the effects of a lifestyle intervention on changes in lifestyle- and health data derived from wearable devices. Cardiac patients from Spain (n = 34) and The Netherlands (n = 36) were included in the current analysis. Data were collected for 210 days, using the Fitbit activity tracker, Beddit sleep tracker, Moves app (GPS tracker), and the Careportal home monitoring system. Locally Weighted Error Sum of Squares regression assessed trajectories of outcome variables. Linear Mixed Effects regression analysis was used to find relevant predictors of improvement deterioration of outcome measures. Analysis showed that Number of Steps and Activity Level significantly changed over time (F = 58.21, p < 0.001; F = 6.33, p = 0.01). No significant changes were observed on blood pressure, weight, and sleep efficiency. Secondary analysis revealed that being male was associated with higher activity levels (F = 12.53, p < 0.001) and higher number of steps (F = 8.44, p < 0.01). Secondary analysis revealed demographic (gender, nationality, marital status), clinical (co-morbidities, heart failure), and psychological (anxiety, depression) profiles that were associated with lifestyle measures. In conclusion results showed that physical activity increased over time and that certain subgroups of patients were more likely to have a better lifestyle behaviors based on their demographic, clinical, and psychological profile. This advocates a personalized approach in future studies in order to change lifestyle in cardiac patients.
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Interaction Between Type 2 Diabetes Prevention Strategies and Genetic Determinants of Coronary Artery Disease on Cardiometabolic Risk Factors.
Merino, J, Jablonski, KA, Mercader, JM, Kahn, SE, Chen, L, Harden, M, Delahanty, LM, Araneta, MRG, Walford, GA, Jacobs, SBR, et al
Diabetes. 2020;69(1):112-120
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Individual risk of Coronary Artery Disease (CAD) and type 2 diabetes reflects the interplay between lifestyle behaviours acting on a backdrop of genetic predisposition. The aim of this study was to examine whether type 2 diabetes prevention strategies, either an intensive lifestyle intervention (ILS) or metformin treatment (MET), modify the association between CAD genetic risk and cardiometabolic risk factors (CRFs) in participants at high risk of type 2 diabetes. The study is a randomised controlled trial were participants were randomly allocated to one of the three groups; ILS (n = 1,079), MET (850 mg twice daily [n = 1,073]), or placebo (n = 1,082). Results indicate that there weren’t major significant differences in baseline characteristics, except for lower high-density lipoprotein and higher triglyceride in the placebo individuals compared with individuals assigned to MET or ILS. In fact, either an ILS or MET has a beneficial effect on 1-year change in different CRFs. Authors conclude that type 2 diabetes–preventive strategies for individuals at high risk of type 2 diabetes provide beneficial effects on CRFs regardless of CAD genetic risk profile.
Abstract
Coronary artery disease (CAD) is more frequent among individuals with dysglycemia. Preventive interventions for diabetes can improve cardiometabolic risk factors (CRFs), but it is unclear whether the benefits on CRFs are similar for individuals at different genetic risk for CAD. We built a 201-variant polygenic risk score (PRS) for CAD and tested for interaction with diabetes prevention strategies on 1-year changes in CRFs in 2,658 Diabetes Prevention Program (DPP) participants. We also examined whether separate lifestyle behaviors interact with PRS and affect changes in CRFs in each intervention group. Participants in both the lifestyle and metformin interventions had greater improvement in the majority of recognized CRFs compared with placebo (P < 0.001) irrespective of CAD genetic risk (P interaction > 0.05). We detected nominal significant interactions between PRS and dietary quality and physical activity on 1-year change in BMI, fasting glucose, triglycerides, and HDL cholesterol in individuals randomized to metformin or placebo, but none of them achieved the multiple-testing correction for significance. This study confirms that diabetes preventive interventions improve CRFs regardless of CAD genetic risk and delivers hypothesis-generating data on the varying benefit of increasing physical activity and improving diet on intermediate cardiovascular risk factors depending on individual CAD genetic risk profile.
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Total and Subtypes of Dietary Fat Intake and Its Association with Components of the Metabolic Syndrome in a Mediterranean Population at High Cardiovascular Risk.
Julibert, A, Bibiloni, MDM, Bouzas, C, Martínez-González, MÁ, Salas-Salvadó, J, Corella, D, Zomeño, MD, Romaguera, D, Vioque, J, Alonso-Gómez, ÁM, et al
Nutrients. 2019;11(7)
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Obesity, Metabolic Syndrome (MetS) and Cardiovascular Disease (CVD) are becoming a global epidemic and the role of dietary fats is still unclear. The PREDIMED trial is a large study of 6560 Mediterranean men and women, aged 55–75 years old, with overweight/obesity and MetS in which they have tracked all types of dietary fat consumed over a 6-year period to assess the risk factors for CVD. Quality of fat is thought to play an important role in MetS. This study used food questionnaires to measure intake of the following fats: total fat, monounsaturated fatty acids: MUFA, polyunsaturated fatty acids: PUFA, saturated fatty acids: SFA, trans-fatty acids: trans-FA, linoleic acid, a-linolenic acid, and w-3 FA). They were able to divide the participants into groups ranging from highest to lowest fat intake and assess the types of foods and fats being consumed. They found that the group with the highest fat intakes ate less carbohydrates, protein and fibre and had a higher risk of hyperglycaemia (high blood glucose levels). The total fats consumed in this group also included high levels of harmful trans-fatty acids so the researchers concluded that the risk is influenced by the combination of nutrients of the food consumed. They also found that participants who consumed high levels of linoleic acid had significantly higher healthy HDL cholesterol levels and those who consumed high levels of saturated fatty acids and omega 3 had significantly less risk of high triglycerides (another cholesterol marker). Overall they recommend further studies into types of dietary fat to help reduce MetS in the population.
Abstract
Background: The effect of dietary fat intake on the metabolic syndrome (MetS) and in turn on cardiovascular disease (CVD) remains unclear in individuals at high CVD risk. Objective: To assess the association between fat intake and MetS components in an adult Mediterranean population at high CVD risk. Design: Baseline assessment of nutritional adequacy in participants (n = 6560, men and women, 55-75 years old, with overweight/obesity and MetS) in the PREvención con DIeta MEDiterránea (PREDIMED)-Plus randomized trial. Methods: Assessment of fat intake (total fat, monounsatured fatty acids: MUFA, polyunsaturated fatty acids: PUFA, saturated fatty acids: SFA, trans-fatty acids: trans-FA, linoleic acid, α-linolenic acid, and ω-3 FA) using a validated food frequency questionnaire, and diet quality using 17-item Mediterranean dietary questionnaire and fat quality index (FQI). Results: Participants in the highest quintile of total dietary fat intake showed lower intake of energy, carbohydrates, protein and fiber, but higher intake of PUFA, MUFA, SFA, TFA, LA, ALA and ω-3 FA. Differences in MetS components were found according to fat intake. Odds (5th vs. 1st quintile): hyperglycemia: 1.3-1.6 times higher for total fat, MUFA, SFA and ω-3 FA intake; low high-density lipoprotein cholesterol (HDL-c): 1.2 higher for LA; hypertriglyceridemia: 0.7 lower for SFA and ω-3 FA intake. Conclusions: Dietary fats played different role on MetS components of high CVD risk patients. Dietary fat intake was associated with higher risk of hyperglycemia.
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One- and Two-Year Effects of the Healthy Primary School of the Future on Children's Dietary and Physical Activity Behaviours: A Quasi-Experimental Study.
Bartelink, NHM, van Assema, P, Kremers, SPJ, Savelberg, HHCM, Oosterhoff, M, Willeboordse, M, van Schayck, OCP, Winkens, B, Jansen, MWJ
Nutrients. 2019;11(3)
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Diet and Physical Activity (PA) habits are formed at a young age, and unhealthy habits can lead to childhood obesity and lifelong health problems. Schools are globally recognised as having access to children across all socio-economic backgrounds and to play an important role in influencing healthy habits. This Dutch experimental longitudinal study looks at the impact Primary schools can have on the health of their students by implementing a dedicated Nutrition and PA Program called ‘Healthy Primary Schools for the Future (HPSF), modelled on an American initiative, piloted in 4 schools and 2 control schools. The study tests whether a fully implemented program (focused on Nutrition and PA - including free lunches & daily PA sessions) or a partial program (focused only on PA sessions) influences healthy change in children’s behaviours versus control schools (no program). The data from 1676 children aged 4-12 yrs was used and the study took place over 3 yrs (2015-2017) with a commitment to continue till 2019 where follow-up data could be obtained. The data was collected once a year using parental and child questionnaires. Additional movement data was obtained from accelerometers the children wore for 7 days during each annual measurement week. The results at year 3 show that a combined nutrition and PA program had greatest benefits on improving diet (variety of foods eaten), and reducing unhealthy snacking, and increasing PA. Neither the partial program or control schools displayed positive changes. The researchers reflect that the full program allowed greater involvement from all parties involved (schools, parents, children’s, educational and health partners) which led to changes becoming an integral part of the school routine. Focusing on nutrition and PA together seemed to encourage complementary behavioural changes compared to focusing only on PA.
Abstract
Schools can help to improve children's health. The 'Healthy Primary School of the Future' (HPSF) aims to sustainably integrate health and well-being into the school system. This study examined the effects of HPSF on children's dietary and physical activity (PA) behaviours after 1 and 2 years' follow-up. The study (n = 1676 children) has a quasi-experimental design with four intervention schools, i.e., two full HPSF (focus: nutrition and PA) and two partial HPSF (focus: PA), and four control schools. Accelerometers and child- and parent-reported questionnaires were used at baseline, after 1 (T1) and 2 (T2) years. Mixed-model analyses showed significant favourable effects for the full HPSF versus control schools for, among others, school water consumption (effect size (ES) = 1.03 (T1), 1.14 (T2)), lunch intake of vegetables (odds ratio (OR) = 3.17 (T1), 4.39 (T2)) and dairy products (OR = 4.43 (T1), 4.52 (T2)), sedentary time (ES = -0.23 (T2)) and light PA (ES = 0.22 (T2)). Almost no significant favourable effects were found for partial HPSF compared to control schools. We conclude that the full HPSF is effective in promoting children's health behaviours at T1 and T2 compared with control schools. Focusing on both nutrition and PA components seems to be more effective in promoting healthy behaviours than focusing exclusively on PA.
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Effect of a lifestyle intervention in obese infertile women on cardiometabolic health and quality of life: A randomized controlled trial.
van Dammen, L, Wekker, V, van Oers, AM, Mutsaerts, MAQ, Painter, RC, Zwinderman, AH, Groen, H, van de Beek, C, Muller Kobold, AC, Kuchenbecker, WKH, et al
PloS one. 2018;13(1):e0190662
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Obesity is linked to increase in cardiovascular and related disease risk factors. The rate of prevalence of obesity in childbearing women is on the increase. Based on these data one of the largest randomised control multicentre Lifestyle study was conducted. The aim of this study was to look into the effects of lifestyle intervention on cardio metabolic risk factors in childbearing obese women. The intervention goal was weight loss of 5-10% within six month. The intervention included caloric restriction and moderate physical activity. The result from the study showed lifestyle intervention among obese infertile women improved cardio metabolic health and also their physical quality of life. The authors concluded that based on data from this study infertile obese women, especially prior to infertility treatment, should be informed of the positive effects of lifestyle intervention of diet and physical activity.
Abstract
BACKGROUND The prevalence of obesity, an important cardiometabolic risk factor, is rising in women. Lifestyle improvements are the first step in treatment of obesity, but the success depends on factors like timing and motivation. Women are especially receptive to advice about lifestyle before and during pregnancy. Therefore, we hypothesize that the pre-pregnancy period provides the perfect window of opportunity to improve cardiometabolic health and quality of life of obese infertile women, by means of a lifestyle intervention. METHODS AND FINDINGS Between 2009-2012, 577 infertile women between 18 and 39 years of age, with a Body Mass Index of ≥ 29 kg/m2, were randomized to a six month lifestyle intervention preceding infertility treatment, or to direct infertility treatment. The goal of the intervention was 5-10% weight loss or a BMI < 29 kg/m2. Cardiometabolic outcomes included weight, waist- and hip circumference, body mass index, systolic and diastolic blood pressure, fasting glucose and insulin, HOMA-IR, hs-CRP, lipids and metabolic syndrome. All outcomes were measured by research nurses at randomization, 3 and 6 months. Self-reported quality of life was also measured at 12 months. Three participants withdrew their informed consent, and 63 participants discontinued the intervention program. Intention to treat analysis was conducted. Mixed effects regression models analyses were performed. Results are displayed as estimated mean differences between intervention and control group. Weight (-3.1 kg 95% CI: -4.0 to -2.2 kg; P < .001), waist circumference (-2.4 cm 95% CI: -3.6 to -1.1 cm; P < .001), hip circumference (-3.0 95% CI: -4.2 to -1.9 cm; P < .001), BMI (-1.2 kg/m2 95% CI: -1.5 to -0.8 kg/m2; P < .001), systolic blood pressure (-2.8 mmHg 95% CI: -5.0 to -0.7 mmHg; P = .01) and HOMA-IR (-0.5 95% CI: -0.8 to -0.1; P = .01) were lower in the intervention group compared to controls. Hs-CRP and lipids did not differ between groups. The odds ratio for metabolic syndrome in the intervention group was 0.53 (95% CI: 0.33 to 0.85; P < .01) compared to controls. Physical QoL scores were higher in the lifestyle intervention group (2.2 95% CI: 0.9 to 3.5; P = .001) while mental QoL scores did not differ. CONCLUSIONS In obese infertile women, a lifestyle intervention prior to infertility treatment improves cardiometabolic health and self-reported physical quality of life (LIFEstyle study: Netherlands Trial Register: NTR1530).
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Patient-Reported Outcome Measures 2 Years After Standard and Distal Gastric Bypass-a Double-Blind Randomized Controlled Trial.
Svanevik, M, Risstad, H, Karlsen, TI, Kristinsson, JA, Småstuen, MC, Kolotkin, RL, Søvik, TT, Sandbu, R, Mala, T, Hjelmesæth, J
Obesity surgery. 2018;28(3):606-614
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Bariatric surgery may induce weight loss, improvement of weight-associated comorbidities, and improved health and well-being. The aim of the study is to compare the effects of standard and distal Rou-en-Y gastric bypass on obesity-specific health related quality of life, weight-related symptoms, eating behaviour, anxiety and depression. The study is a double-blind, parallel-group randomised controlled trial. The participants’ age ranged from 18 to 60 years of age with a BMI of 50 to 60 kg/m2. Results indicated improvements in most patient-reported outcome measures after both surgeries, but no significant difference between groups after surgery in relation to obesity-specific health related quality of life, weight-related symptoms, anxiety and depression, or eating behaviour. Authors conclude that both surgeries lead to sustained weight loss and improved health related quality of life 2 years after surgery in patients with a BMI 50-60kg/m2.
Abstract
BACKGROUND The preferred surgical procedure for treating morbid obesity is debated. Patient-reported outcome measures (PROMs) are relevant for evaluation of the optimal bariatric procedure. METHODS A total of 113 patients with BMI from 50 to 60 were randomly assigned to standard (n = 57) or distal (n = 56) Roux-en-Y gastric bypass (RYGB). Validated PROMS questionnaires were completed at baseline and 2 years after surgery. Data were analyzed using mixed models for repeated measures and the results are expressed as estimated means and mean changes. RESULTS Obesity-related quality of life improved significantly after both procedures, without significant between-group differences (- 0.4 (95% CI = - 8.4, 7.2) points, p = 0.88, ES = 0.06). Both groups had significant reductions in the number of weight-related symptoms and symptom distress score, with a mean group difference (95% CI) of 1.4 (- 0.3, 3.3) symptoms and 5.0 (2.9. 12.8) symptom distress score points. There were no between-group differences for uncontrolled eating (22.0 (17.2-26.7) vs. 28.9 (23.3-34.5) points), cognitive restraint (57.4 (52.0-62.7) vs. 62.1 (57.9-66.2) points), and emotional eating (26.8 (20.5-33.1) vs. 32.6 (25.5-39.7) points). The prevalence of anxiety was 33% after standard and 25% after distal RYGB (p = 0.53), and for depression 12 and 9%, respectively (p = 0.76). CONCLUSIONS There were no statistically significant differences between standard and distal RYGB 2 years post surgery regarding weight loss, obesity-related quality of life, weight-related symptoms, anxiety, depression, or eating behavior. TRIAL REGISTRATION Clinical Trials.gov number NCT00821197.
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Change in physical activity level and clinical outcomes in older adults with knee pain: a secondary analysis from a randomised controlled trial.
Quicke, JG, Foster, NE, Croft, PR, Ogollah, RO, Holden, MA
BMC musculoskeletal disorders. 2018;19(1):59
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Exercise improves pain and function in adults with knee pain due to osteoarthritis. To date, no studies have investigated if changes in physical activity level can explain this improvement in pain and function. This longitudinal study aimed to investigate if change in physical activity during exercise interventions is associated with future pain and physical function in older adults with knee pain. Participants were adults over the age of 45, who were already taking part in a trial of exercise interventions on knee pain. Change in physical activity was measured using a self-reported scale from baseline to 3 months. Pain and physical function were measured at baseline, 3 months and 6 months. Change in physical activity level was not associated with pain or physical function at 3 or 6 months. The authors suggest that other factors may be responsible for clinical improvements following exercise interventions, and recommend further investigation into the responsiveness of commonly used physical activity measures.
Abstract
BACKGROUND Exercise interventions improve clinical outcomes of pain and function in adults with knee pain due to osteoarthritis and higher levels of physical activity are associated with lower severity of pain and higher levels of physical functioning in older adults with knee osteoarthritis in cross-sectional studies. However, to date no studies have investigated if change in physical activity level during exercise interventions can explain clinical outcomes of pain and function. This study aimed to investigate if change in physical activity during exercise interventions is associated with future pain and physical function in older adults with knee pain. METHODS Secondary longitudinal data analyses of a three armed exercise intervention randomised controlled trial. Participants were adults with knee pain attributed to osteoarthritis, over the age of 45 years old (n = 514) from Primary Care Services in the Midlands and Northwest regions of England. Crude and adjusted associations between absolute change in physical activity from baseline to 3 months (measured by the self-report Physical Activity Scale for the Elderly (PASE)) and i) pain ii) physical function (Western Ontario and McMaster Universities Osteoarthritis Index) and iii) treatment response (OMERACT-OARSI responder criteria) at 3 and 6 months follow-up were investigated using linear and logistic regression. RESULTS Change in physical activity level was not associated with future pain, function or treatment response outcomes in crude or adjusted models at 3 or 6 months (P > 0.05). A 10 point increase in PASE was not associated with pain β = - 0.01 (- 0.05, 0.02), physical function β = - 0.09 (- 0.19, 0.02) or likelihood (odds ratio) of treatment response 1.02 (0.99, 1.04) at 3 months adjusting for sociodemographics, clinical covariates and the trial intervention arm. Findings were similar for 6 month outcome models. CONCLUSIONS Change in physical activity did not explain future clinical outcomes of pain and function in this study. Other factors may be responsible for clinical improvements following exercise interventions. However, the PASE may not be sufficiently responsive to measure change in physical activity level. We also recommend further investigation into the responsiveness of commonly used physical activity measures. TRIAL REGISTRATION ( ISRCTN93634563 ). Registered 29th September 2011.