The usefulness of randomized trials of lifestyle interventions for overweight, obesity, or metabolic syndrome: A systematic review.

BACKGROUND: Randomized controlled trials (RCTs) widely considered the gold standard for evidence-based healthcare may be limited in their clinical usefulness in lifestyle interventions for adults with overweight, obesity, or metabolic syndrome. OBJECTIVE: In this systematic review of lifestyle intervention RCTs we delineated trial usefulness. METHODS: Following prospective registration in PROSPERO (CRD4202347896), we conducted a comprehensive search across Medline, Scopus, Web of Science, and the Cochrane Library databases, covering the period from inception to December 2023. RCTs involving dietary interventions, with or without physical activity, and with or without behavioural support were included. Two reviewers independently performed study selection and data extraction. Study usefulness was assessed using a multidimensional 14 item questionnaire. Percentage compliance with usefulness items was computed. RESULTS: Of 1175 records, 30 RCTs (12,841 participants) were included. Among these, 13 (43%) RCTs complied with half of the usefulness items and only 3 (10%) complied with two-thirds of the items. For each usefulness item individually: 30 (100%) reported the burden of the problem addressed, 15 (50%) contextualized the trial through a systematic review, 18 (60%) presented an informative trial with clinically meaningful outcomes evaluated at a stated statistical power, 17 (57%) had low risk of bias, 2 (7%) exhibited pragmatic features pertaining to the trial methodologies and outcomes relevant to real-world application.18 (60%) were patient centred with formal patient involvement, none (0%) demonstrated value for money, 17 (57%) were completed according to their feasibility assessment achieving at least 90% of the estimated sample size, and 30 (100%) reported at least one of five transparency or openness features. CONCLUSION: Only one in 10 lifestyle RCTs met two-thirds of the usefulness features. It is imperative to meet these criteria when devising future trials within the field of nutrition to reduce research waste.

Sex-specific dietary patterns and their association with metabolic syndrome: Insights from a cross-sectional analysis.

AIMS: This study aims to identify a posteriori dietary patterns with a sex approach and to evaluate their association with metabolic syndrome criteria. METHODS: Cross-sectional study conducted in 6821 men and women between 55 and 75 years of age. Forty-two food groups were analyzed from dietary information collected with food frequency questionnaires, using principal component analysis and cluster analysis and then information from both statistical methods was compared. Prevalences were calculated foreach cluster group, based on the number and types of metabolic syndrome criteria they met. RESULTS: Following principal component analysis, two dietary patterns labeled "healthy" and "unhealthy" were identified in both men and women, due to the presence of foods that are considered more or less healthy. These same dietary patterns were found in cluster analysis plus an "intermediate" cluster consisting of both healthy and unhealthy foods. The presence of metabolic syndrome is related to the "healthy" dietary pattern in women and to the "unhealthy" dietary pattern in men. Comparison of the two statistical approaches showed a high level of correlation between them (weighted Kappa = 0.703 in women and weighted Kappa = 0.691 in men). CONCLUSIONS: Adherence to both healthy and unhealthy dietary pattern appears to be related to the development of MS. The differences found by sex make it necessary to develop interventions with a sex-specific approach.

Prevalence of obstetric violence in high-income countries: A systematic review of mixed studies and meta-analysis of quantitative studies.

INTRODUCTION: Obstetric violence, or mistreatment of women in obstetric care, can have severe consequences such as fear of future childbirth, post-traumatic stress disorder, and depression. MATERIAL AND METHODS: The primary objective was to estimate the prevalence of obstetric violence in high-income countries. The secondary objective was to extract the main domains of obstetric violence perceived by women from qualitative studies. Following prospective registration (PROSPERO CRD42023468570), PubMed, Web of Science, Scopus, CINAHL, Embase, and Cochrane Library were searched with no restrictions. Included studies were cross-sectional, cohort, mixed methods, and qualitative studies based on populations from high-income countries. The review was conducted by two independent reviewers. Risk of bias was assessed. Rates of obstetric violence were pooled using random effects model, computing 95% confidence intervals (CI) and assessing heterogeneity using I2 statistic. Funnel plots and Egger's test were used to detect potential reporting biases and small-study effects. RESULTS: Of the 1821 records screened, 25 studies were included: 14 quantitative and 2 mixed methods studies, comprising 60 987 women, and 9 qualitative studies were included, comprising an additional 4356 women. 81.25% of quantitative studies, including the quantitative component of the mixed methods studies, were considered satisfactory or better regarding risk of bias. The prevalence of obstetric violence was overall 45.3% (95% CI 27.5-63.0; I2 = 100.0%). The prevalence of specific forms of mistreatment was also estimated. Lack of access to analgesia was 17.3% (95% CI 6.9-27.7; I2 = 99.7%). Ignored requests for help was 19.2% (95% CI 11.7-26.6; I2 = 99.0%). Shouting and scolding 19.7% (95% CI 13.0-26.4; I2 = 98.7%). The use of fundal pressure during the second stage of labor (Kristeller maneuver) was 30.3% (95% CI 22.1-38.5; I2 = 97.6%). There was no funnel asymmetry. Lack of information and/or consent were the most frequent domains extracted from the qualitative articles and the qualitative component of the mixed methods studies. CONCLUSIONS: The results demonstrate that obstetric violence is a prevalent problem that women in high-income countries experience. Lack of information and/or consent were the domains most frequently described in the qualitative studies and the qualitative component of the mixed methods studies.

Objectively Measured Sleep Duration and Health-Related Quality of Life in Older Adults with Metabolic Syndrome: A One-Year Longitudinal Analysis of the PREDIMED-Plus Cohort.

The aim of our cross-sectional and longitudinal study is to assess the relationship between daytime and night-time sleep duration and health-related quality of life (HRQoL) in adults with metabolic syndrome after a 1-year healthy lifestyle intervention. Analysis of the data from 2119 Spanish adults aged 55-75 years from the PREDIMED-Plus study was performed. Sleep duration was assessed using a wrist-worn accelerometer. HRQoL was measured using the SF-36 questionnaire. Linear regression models adjusted for socioeconomic and lifestyle factors and morbidity were developed. In cross-sectional analyses, participants with extreme night-time sleep duration categories showed lower physical component summary scores in Models 1 and 2 [ß-coefficient (95% confidence interval) <6 h vs. 7-9 h: -2, 3 (-3.8 to -0.8); p = 0.002. >9 h vs. 7-9 h: -1.1 (-2.0 to -0.3); p = 0.01]. Participants who sleep less than 7 h a night and take a nap are associated with higher mental component summary scores [ß-coefficient (95% confidence interval) 6.3 (1.3 to 11.3); p = 0.01]. No differences between night-time sleep categories and 12-month changes in HRQoL were observed. In conclusion, in cross-sectional analyses, extremes in nocturnal sleep duration are related to lower physical component summary scores and napping is associated with higher mental component summary scores in older adults who sleep less than 7 h a night.

Long-term association between water intake and kidney function in a population at high cardiovascular risk.

OBJECTIVES: The evidence on water intake in the prevention of kidney function decline is scarce at population level in well-being individuals at high cardiovascular risk. Therefore, we aimed to longitudinally evaluate the associations between total water intake and subtypes and kidney function, through estimated-Glomerular Filtration Rate (eGFR). METHODS: Three-year prospective analysis conducted in 1986 older adults (aged 55-75 year) with overweight/obesity and metabolic syndrome from the PREDIMED-Plus study. Water intake was assessed using validated beverage and food frequency questionnaires. Serum creatinine-based eGFR (SCr-based eGFR; ml/min/1.73 m2) was estimated using the CKD-EPI equation at baseline, one-year and 3-years of follow-up. Mixed-effects linear regression models were fitted to evaluate the associations between baseline total water intake and subtypes, and SCr-based eGFR over 3-years of follow-up. RESULTS: Participants in the highest baseline tertile of total water intake, plain water and water from all fluids showed a lower decrease in SCr-based eGFR after 3-years of follow-up, compared to those in the lowest tertile. Participants with the highest tap water consumption showed a lower SCr-based eGFR decline after 1-year and 3-years of follow-up, in comparerd to participants in the lowest intake category (T3 vs. T1: ß: 1.4 ml/min/1.73 m2; 95%CI: 0.5-2.3, ß: 1.0; 95%CI: 0.1-2.0, respectively). CONCLUSIONS: Plain water rather than other water sources, and especially tap water, was associated with lower kidney function decline assessed through eGFR over 3-years of follow-up, in older individuals at high cardiovascular risk. TRIAL REGISTRATION: ISRCTN89898870. Retrospectively registered on 24 July 2014.

More Adult Women than Men at High Cardiometabolic Risk Reported Worse Lifestyles and Self-Reported Health Status in the COVID-19 Lockdown.

BACKGROUND: The COVID-19 lockdown represented an immense impact on human health, which was characterized by lifestyle and dietary changes, social distancing and isolation at home. Some evidence suggests that these consequences mainly affected women and altered relevant ongoing clinical trials. The aim of this study was to evaluate the status and changes in diet, physical activity (PA), sleep and self-reported health status (SRH) as perceived by older adult men and women with metabolic syndrome during the COVID-19 lockdown. METHODS: We analyzed data from 4681 Spanish adults with metabolic syndrome. We carried out a telephone survey during May and June 2020 to collect information on demographics, dietary habits, PA, sleep, SRH and anthropometric data. RESULTS: The mean age of participants was 64.9 years at recruitment, and 52% of participants were men. Most participants (64.1%) perceived a decrease in their PA during confinement. Regarding gender-specific differences, a higher proportion of women than men perceived a decrease in their PA (67.5% vs. 61.1%), Mediterranean diet adherence (20.9% vs. 16.8%), sleep hours (30.3% vs. 19.1%), sleep quality (31.6% vs. 18.2%) and SRH (25.9% vs. 11.9%) (all p < 0.001). CONCLUSIONS: The COVID-19 lockdown affected women more negatively, particularly their self-reported diet, PA, sleep and health status.

Prevalence of depression and anxiety in women with pelvic floor dysfunctions: A systematic review and meta-analysis.

BACKGROUND: Female pelvic floor dysfunction (PFD) is a common condition affecting the emotional well-being of women. OBJECTIVE: To estimate the prevalence of depressive and anxiety symptoms in women with PFD. SEARCH STRATEGY, SELECTION CRITERIA, DATA COLLECTION AND ANALYSIS: Following prospective registration (PROSPERO CRD42022362095) we conducted a search of three electronic databases (PubMed, Web of Science and Scopus) from inception to April 2023 without language restriction to capture studies reporting the prevalence of depression/anxiety among women with PFD (chronic pelvic pain [CPP], urinary incontinence [UI], pelvic organ prolapse [POP], and/or fecal incontinence [FI]). Only studies with validated tools were included. Data extraction and study quality assessment were performed by two independent reviewers. Stratifying by type of PFD, rates of depression and anxiety were pooled using random effects model computing 95% confidence interval (CI) and assessing heterogeneity using the I2 statistic. Funnel plots were used to detect potential reporting biases and small-study effects. MAIN RESULTS: The search yielded 767 articles, from which 54 studies containing 632 605 women were included. All the studies were high quality. The prevalence of depression was: CPP 26.8% (95% CI: 19.2-34.4, I2 = 98.7%; 12 studies, 4798 participants with 491 cases; Egger's P value = 0.009); UI 26.3% (95% CI: 19.4-33.2, I2 = 99.9%; 26 studies, a total of 346 114 participants with 25 050 cases; Egger's P value = 0.944); POP 34.9% (95% CI: 24.3-45.6, I2 = 68%; three studies, 297 participants with 104 cases; Egger's P value = 0.973); and FI 25.3% (95% CI: 0.68-49.9, I2 = 99.7%; six studies, 14 663 participants with 1773 cases; Egger's P value = 0.780). The prevalence of anxiety was: CPP 29.5% (95% CI: 16.3-42.7, I2 = 97.7%; nine studies, 2483 participants with 349 cases; Egger's P value = 0.001); UI 46.91% (95% CI: 39.1-54.6, I2 = 99.6%; 11 studies, 198 491 participants with 40 058 cases; Egger's P value = 0.337); and POP 28% (95% CI: 13.6-42.4, I2 = 89%; three studies with 355 participants with 90 cases; Egger's P value = 0.306). CONCLUSION: The prevalence of mental health illness was variable in the different types of PFDs. This meta-analysis helps quantify the burden of depression and anxiety in PFD and will help inform the policies regarding screening of emotional well-being by healthcare professionals engaged in care of women with PFD.

Effect of a nutritional intervention based on an energy-reduced Mediterranean diet on environmental impact.

OBJECTIVE: To estimate the environmental impact of a dietary intervention based on an energy-reduced Mediterranean diet (MedDiet) after one year of follow-up. METHODS: Baseline and 1-year follow-up data were used for 5800 participants aged 55-75 years with metabolic syndrome in the PREDIMED-Plus study. Food intake was estimated through a validated semiquantitative food consumption frequency questionnaire, and adherence to the MedDiet was estimated through the Diet Score. Using the EAT-Lancet Commission tables we assessed the influence of dietary intake on environmental impact (through five indicators: greenhouse gas emissions (GHG), land use, energy used, acidification and potential eutrophication). Using multivariable linear regression models, the association between the intervention and changes in each of the environmental factors was assessed. Mediation analyses were carried out to estimate to what extent changes in each of 2 components of the intervention, namely adherence to the MedDiet and caloric reduction, were responsible for the observed reductions in environmental impact. RESULTS: We observed a significant reduction in the intervention group compared to the control group in acidification levels (-13.3 vs. -9.9 g SO2-eq), eutrophication (-5.4 vs. -4.0 g PO4-eq) and land use (-2.7 vs. -1.8 m2). Adherence to the MedDiet partially mediated the association between intervention and reduction of acidification by 15 %, eutrophication by 10 % and land use by 10 %. Caloric reduction partially mediated the association with the same factors by 55 %, 51 % and 38 % respectively. In addition, adherence to the MedDiet fully mediated the association between intervention and reduction in GHG emissions by 56 % and energy use by 53 %. CONCLUSIONS: A nutritional intervention based on consumption of an energy-reduced MedDiet for one year was associated with an improvement in different environmental quality parameters.

Association between Beverage Consumption and Environmental Sustainability in an Adult Population with Metabolic Syndrome.

Beverages are an important part of the diet, but their environmental impact has been scarcely assessed. The aim of this study was to assess how changes in beverage consumption over a one-year period can impact the environmental sustainability of the diet. This is a one-year longitudinal study of 55-75-year-old participants with metabolic syndrome (n = 1122) within the frame of the PREDIMED-Plus study. Food and beverage intake were assessed using a validated food frequency questionnaire and a validated beverage-specific questionnaire. The Agribalyse® 3.0.1 database was used to calculate environmental impact parameters such as greenhouse gas emission, energy, water, and land use. A sustainability beverage score was created by considering the evaluated environmental markers. A higher beverage sustainability score was obtained when decreasing the consumption of bottled water, natural and packed fruit juice, milk, and drinkable dairy, soups and broths, sorbets and jellies, soft drinks, tea without sugar, beer (with and without alcohol), and wine, as well as when increasing the consumption of tap water and coffee with milk and without sugar. Beverage consumption should be considered when assessing the environmental impact of a diet. Trial registration: ISRCTN, ISRCTN89898870. Registered 5 September 2013.

Lifestyle Interventions in an Aged Population: Challenges and Opportunities from a Public Health Perspective.

In recent decades, the prevalence of non-communicable diseases (NCDs) such as obesity, type 2 diabetes mellitus, cancer and cardiovascular disease has increased worldwide [...].