scholarly journals An Early, Universal Mediterranean Diet-Based Intervention in Pregnancy Reduces Cardiovascular Risk Factors in the “Fourth Trimester”

2019 ◽  
Vol 8 (9) ◽  
pp. 1499 ◽  
Author(s):  
Carla Assaf-Balut ◽  
Nuria Garcia de la Torre ◽  
Alejandra Durán ◽  
Elena Bordiu ◽  
Laura del Valle ◽  
...  
Keyword(s):  
Cardiovascular Risk ◽  
Mediterranean Diet ◽  
Standard Care ◽  
Dietary Intervention ◽  
Metabolic Diseases ◽  
Virgin Olive Oil ◽  
Intervention Group ◽  
Dietary Guidelines ◽  
Care Group ◽  
In Pregnancy

An early antenatal dietary intervention could play an important role in the prevention of metabolic diseases postpartum. The aim of this study is to evaluate whether an early, specific dietary intervention reduces women’s cardiovascular risk in the “fourth trimester”. This prospective cohort study compares 1675 women from the standard-care group (ScG/n = 676), who received standard-care dietary guidelines, with the intervention group (IG/n = 999), who received Mediterranean diet (MedDiet)-based dietary guidelines, supplemented with extra-virgin olive oil and nuts. Cardiovascular risk was determined by the presence of metabolic syndrome (MetS) and insulin resistance syndrome (IrS) (HOMA-IR 3.5) at 12–14 weeks postpartum. MetS was less frequent in the IG (11.3 vs. 19.3%, p < 0.05). The intervention was associated with a reduction in the relative risk of having MetS: 0.74 (95% CI, 0.60–0.90), but not in the risk of IrS. When analyzing the presence of having one or more components of the MetS, the IG had significantly higher rates of having 0 components and lower rates of having ≥1 (p-trend = 0.029). An early MedDiet-based nutritional intervention in pregnancy is associated with reductions in postpartum rates of MetS.

scholarly journals Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial

BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e006571 ◽  
Author(s):  
Della A Forster ◽  
Susan Jacobs ◽  
Lisa H Amir ◽  
Peter Davis ◽  
Susan P Walker ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Breast Milk ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Care Group ◽  
Diabetes In Pregnancy ◽  
Increased Risk ◽  
Randomised Controlled ◽  
In Pregnancy

IntroductionMany maternity providers recommend that women with diabetes in pregnancy express and store breast milk in late pregnancy so breast milk is available after birth, given (1) infants of these women are at increased risk of hypoglycaemia in the first 24 h of life; and (2) the delay in lactogenesis II compared with women without diabetes that increases their infant's risk of receiving infant formula. The Diabetes and Antenatal Milk Expressing (DAME) trial will establish whether advising women with diabetes in pregnancy (pre-existing or gestational) to express breast milk from 36 weeks gestation increases the proportion of infants who require admission to special or neonatal intensive care units (SCN/NICU) compared with infants of women receiving standard care. Secondary outcomes include birth gestation, breastfeeding outcomes and economic impact.Methods and analysisWomen will be recruited from 34 weeks gestation to a multicentre, two arm, unblinded randomised controlled trial. The intervention starts at 36 weeks. Randomisation will be stratified by site, parity and diabetes type. Women allocated to the intervention will be taught expressing and encouraged to hand express twice daily for 10 min and keep an expressing diary. The sample size of 658 (329 per group) will detect a 10% difference in proportion of babies admitted to SCN/NICU (85% power, α 0.05). Data are collected at recruitment (structured questionnaire), after birth (abstracted from medical record blinded to group), and 2 and 12 weeks postpartum (telephone interview). Data analysis: the intervention group will be compared with the standard care group by intention to treat analysis, and the primary outcome compared using χ2 and ORs.Ethics and disseminationResearch ethics approval will be obtained from participating sites. Results will be published in peer-reviewed journals and presented to clinicians, policymakers and study participants.Trial registration numberAustralian Controlled Trials Register ACTRN12611000217909.

scholarly journals The effect of a pharmacist consultation on pregnant women’s quality of life with a special focus on nausea and vomiting: an intervention study

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Maria Bich-Thuy Truong ◽  
Elin Ngo ◽  
Hilde Ariansen ◽  
Ross T. Tsuyuki ◽  
Hedvig Nordeng
Keyword(s):  
Quality Of Life ◽  
Early Pregnancy ◽  
Standard Care ◽  
Intervention Study ◽  
Intervention Group ◽  
Nausea And Vomiting ◽  
Quality Of Life Scale ◽  
The Impact ◽  
In Pregnancy

Abstract Background Maternal wellbeing and quality of life (QOL) are increasingly being recognized as important for healthy pregnancies. The aim of this study was to investigate the impact of a pharmacist consultation on pregnant women’s QOL focusing on nausea and vomiting in pregnancy (NVP), and patient satisfaction. Methods For this intervention study in 14 community pharmacies, women in early pregnancy were recruited and assigned to a pharmacist consultation (intervention) or standard care (control). The consultation aimed to address each woman’s concerns regarding medications and pregnancy-related ailments. Data were collected through online questionnaires at baseline (Q1) and during the second trimester (Q2). The intervention group completed an additional satisfaction questionnaire after the consultation was completed. The primary outcome was the impact of the intervention on the Quality of Life Scale (QOLS) scores between the first and second trimesters. The impact of the intervention was assessed by linear regression, and secondary analyses were performed to assess effect modification by NVP. Results Of the 340 women enrolled in the study, we analyzed data for 245. Half (170/340) of the original participants were allocated to the intervention group, of whom 131 received the pharmacist consultation. Most women (75%, 78/96) reported that the consultation was useful to a large/very large extent. The consultation had no overall impact on QOLS scores between the first and the second trimesters compared with standard care (adjusted β: 0.7, 95% CI: -2.1, 3.4). The impact of the intervention on QOLS was greater amongst women with moderate/severe NVP (adjusted β: 3.6, 95% CI: -0.6, 7.7) compared to those with no/mild NVP (adjusted β: -1.4, 95% CI: -5.1, 2.2) (interaction term study group*NVP severity, p = 0.048). Conclusions The pregnant women highly appreciated the pharmacist consultation, but the intervention did not affect their QOL scores compared with standard care. Future studies should further explore the effect of a pharmacist consultation specifically for NVP and on other outcomes such as use of health care services and medication use in pregnancy. Trial registration Retrospectively registered in ClinicalTrials.gov (identifier: NCT04182750, registration date: December 2, 2019).

scholarly journals Effectiveness of Mediterranean Diet Implementation in Dry Eye Parameters: A Study of PREDIMED-PLUS Trial

Nutrients ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 1289
Author(s):  
Ignacio Molina-Leyva ◽  
Alejandro Molina-Leyva ◽  
Blanca Riquelme-Gallego ◽  
Naomi Cano-Ibáñez ◽  
Laura García-Molina ◽  
...  
Keyword(s):  
Weight Loss ◽  
Olive Oil ◽  
Mediterranean Diet ◽  
Dry Eye ◽  
Virgin Olive Oil ◽  
Intervention Group ◽  
Extra Virgin Olive Oil ◽  
Ocular Surface Disease Index ◽  
Intensive Intervention ◽  
Diet Pattern

The purpose of this study is to evaluate the effect of a Mediterranean diet supplemented with extra virgin olive oil and nuts on dry eye parameters. The participants in this study were randomized into one of the two interventional arms: (1) a standard intervention group, a Mediterranean diet supplemented with extra virgin olive oil and nuts; and (2) an intensive intervention group, based on a hypocaloric Mediterranean diet and an intensive lifestyle program with physical activity and weight-loss goals. In both groups, common dry eye tests were conducted at baseline and after six months: the Ocular Surface Disease Index (OSDI), the Dry Eye Scoring System (DESS), tear break-up time (TBUT), the Schirmer’s test, and the Oxford staining grade. Sixty-seven eyes were examined. After six months, dry eye parameters improved in both groups; differences between groups were favorable for the intensive intervention group. The implementation of a Mediterranean diet pattern was beneficial for the selected patients with dry eye, and could be beneficial for patients with dry eye in general. Behavioral support for diet adherence and the promotion of healthy lifestyles (exercise) and weight loss (calorie restriction) have an added positive effect.

scholarly journals A comparison of hydrophobic polyurethane and polyurethane peripherally inserted central catheter: results from a feasibility randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Nicole C. Gavin ◽  
Tricia M. Kleidon ◽  
Emily Larsen ◽  
Catherine O’Brien ◽  
Amanda Ullman ◽  
...  
Keyword(s):  
Standard Care ◽  
Dwell Time ◽  
Controlled Trial ◽  
Intervention Group ◽  
Trial Registration ◽  
Care Group ◽  
Control Group ◽  
Peripherally Inserted Central Catheter ◽  
Central Catheter ◽  
Efficacy Trial

Abstract Background To evaluate the feasibility of an efficacy trial comparing a hydrophobic polyurethane peripherally inserted central catheter (PICC) with a standard polyurethane PICC. Methods This pilot randomised controlled trial (RCT) was conducted between May 2017 and February 2018. Adult participants (n = 111) were assigned to hydrophobic polyurethane PICC with proximal valve (intervention) or a polyurethane PICC with external clamp (standard care). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were central line-associated bloodstream infection, local infection, occlusion, thrombosis, fracture and dislodgement, phlebitis, local or systemic allergic reaction, and PICC dwell time. Results All feasibility outcomes were achieved, apart from eligibility criteria. In total, 338 patients were screened, 138 were eligible (41%), and of these 111 were randomised (80%). Patients received the allocated PICC in 106 (95%) insertions. No patients withdrew from the study and there was no missing data. PICC failure was 24% (13/55) in the intervention group and 22% (12/55) in the standard care group (p = 0.820). PICC failure per 1000 PICC days was 16.3 in the intervention group and 18.4 in the control group (p = 0.755). The average dwell time was 12 days in the intervention and 8 days in the control group. Conclusions This study demonstrates the feasibility of an efficacy trial of PICC materials in an adult population, once adjustments were made to include not only in-patients, but also patients being discharged to the Hospital in the Home service. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12616001578493. Prospectively registered on 16 November 2016. The trial protocol was published a priori (Kleidon et al., Vasc Access 3:15–21, 2017).

scholarly journals Dietary Pattern Influences Breast Cancer Prognosis in Women Without Hot Flashes: The Women's Healthy Eating and Living Trial

2009 ◽  
Vol 27 (3) ◽  
pp. 352-359 ◽  
Author(s):  
Ellen B. Gold ◽  
John P. Pierce ◽  
Loki Natarajan ◽  
Marcia L. Stefanick ◽  
Gail A. Laughlin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Breast Cancer Survivors ◽  
Dietary Intervention ◽  
Comparison Group ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Intervention Group ◽  
Dietary Guidelines ◽  
Cancer Prognosis

Purpose To determine whether a low-fat diet high in vegetables, fruit, and fiber differentially affects prognosis in breast cancer survivors with hot flashes (HF) or without HF after treatment. Patients and Methods A secondary analysis was conducted on 2,967 breast cancer survivors, age 18 to 70 years, who were randomly assigned between 1995 and 2000 in a multicenter, controlled trial of a dietary intervention to prevent additional breast cancer events and observed through June 1, 2006. We compared the dietary intervention group with a group who received five-a-day dietary guidelines. Results Independent of HF status, a substantial between-group difference among those who did and did not receive dietary guidelines was achieved and maintained at 4 years in intake of vegetable/fruit servings per day (54% higher; 10 v 6.5 servings/d, respectively), fiber (31% higher; 25.5 v 19.4 g/d, respectively), and percent energy from fat (14% lower; 26.9% v 31.3%, respectively). Adjusting for tumor characteristics and antiestrogen treatment, HF-negative women assigned to the intervention had 31% fewer events than HF-negative women assigned to the comparison group (hazard ratio [HR] = 0.69; 95% CI, 0.51 to 0.93; P = .02). The intervention did not affect prognosis in the women with baseline HFs. Furthermore, compared with HF-negative women assigned to the comparison group, HF-positive women had significantly fewer events in both the intervention (HR = 0.77; 95% CI, 0.59 to 1.00; P = .05) and comparison groups (HR = 0.65; 95% CI, 0.49 to 0.85; P = .002). Conclusion A diet with higher vegetable, fruit, and fiber and lower fat intakes than the five-a-day diet may reduce risk of additional events in HF-negative breast cancer survivors. This suggestive finding needs confirmation in a trial in which it is the primary hypothesis.

scholarly journals Efficacy of Levamisole with Standard Care Treatment vs Standard Care in Clinical Presentations of Non-Hospitalized Patients with COVID-19: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Mohammad Hossein Asgardoon ◽  
Hamid Emadi koochak ◽  
Mohammad Hassan Kazemi-Galougahi ◽  
Ali Zare Dehnavi ◽  
Behzad Khodaei ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
General Health ◽  
Standard Care ◽  
Intervention Group ◽  
Health Condition ◽  
Hospitalized Patients ◽  
Care Group ◽  
Control Group ◽  
Significant Difference ◽  
General Health Condition

Abstract Introduction: Levamisole (LVM) demonstrated clinical benefit in a trial in patients with mild to moderate coronavirus disease 2019 (COVID-19), but its effect in a larger sample size needs to be confirmed. Methods In this randomized open-label trial, we enrolled non-hospitalized patients with mild to moderate COVID-19 at nine health centers in Tehran province, Iran, in 2021. Patients were randomly assigned to receive a 10-day course of LVM with standard care (n = 185), or standard care (n = 180) in a 1:1 ratio. On days 1 to 10, LVM was administered orally at a dosage of 50 mg. The participants were called and followed on days 1, 3, 5, 7, 9, and 14. The outcomes were general health condition, hospitalization rate, sign and symptoms, and adverse events (AEs). Generalized Estimating Equations model was used for analysis. Results Among 507 randomized patients, 473 started the experiment and received LVM in addition to standard care or received only the standard care (median age, 40 [IQR, 32-50.75] years; 164 [44.9%] women; 9.4% had diabetes, 8.8% hypertension, 1.6% cardiovascular disease), and 346 (98%) completed the trial. Compared to control group, LVM decreased the general health condition of the patients (B=-0.635; CI= -0.041, -0.329; P= 0.000). Patients in the LVM with standard care group had significantly lower odds of developing fever (OR= 0.260; 95% CI= ‎0.11‎‎3‎-0.59‎‎9‎; P = .002), chills (OR= 0.223; 95% CI= ‎‎0.07‎‎6‎-‎0.64‎‎8‎; P = 0.006), fatigue (OR= 0.576; 95% CI= ‎0.34‎‎6‎-‎0.96‎‎0‎‎; P = ‎0.034), and myalgia (OR= 0.54‎‎4‎; 95% CI= ‎0.31‎‎7‎-‎0.93‎‎2‎‎; P =0.027). During the therapy, there was no significant difference in the parameters of dyspnea, cough, diarrhea, nausea, vomiting, sore throat, hyposmia, dysgeusia, and anorexia (P > 0.05). No significant difference was observed in the rate of hospitalization. Although the intervention group had greater AEs than the control group, yet, the difference was not statistically significant. Conclusions LVM has clinical benefit in improving health condition of patients with mild to moderate COVID-19. Further studies are needed to confirm our findings. Trial Registration: Iranian Registry of Clinical Trials: IRCT20201124049480N1; Registration date: 28/03/2021.

Abstract 19836: Lipid Metabolism is Modified by the Interaction Between Cholesteryl Ester Transfer Protein Gene Polymorphism and Mediterranean Diet in Patients in Secondary Prevention for Cardiovascular Disease

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Antonio Garcia Rios ◽  
Francisco Gomez-Delgado ◽  
Ana Isabel Perez Caballero ◽  
Andreea Corina-Baba ◽  
Vanesa Navarro-Martos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lipid Metabolism ◽  
Cholesteryl Ester ◽  
Mediterranean Diet ◽  
Cholesteryl Ester Transfer Protein ◽  
Dietary Intervention ◽  
Intervention Group ◽  
Low Fat ◽  
Transfer Protein ◽  
The Impact

Introduction: Cholesteryl ester transfer protein (CETP) gene has been implicated in lipid metabolism. However, little is known about the impact of this gene on coronary heart disease (CHD) patients and its interaction with diet. Hypothesis: To evaluate whether the chronic consumption of a Mediterranean diet enriched in olive oil, compared with a Low fat diet, interacts with the rs3764261 SNP at CETP locus in order to modify lipid metabolism among MetS patients from the CORDIOPREV clinical trial Methods: Plasma lipid concentrations and rs3764261 genotypes were determined in 424 MetS subjects participating in the CORDIOPREV clinical trial. Gene-diet interactions were analyzed after a year of dietary intervention (Mediterranean diet (35% fat, 22% MUFA) vs Low fat diet (28% fat, 12% MUFA)) Results: We found significant gene-diet interactions between rs3764261 SNP and the dietary pattern for HDL-C ( P=0.006 ) and triglyceride concentrations ( P=0.040 ). Specifically, after 12 months of Mediterranean diet intervention, subjects who were carriers of the minor T allele (TT+TG) displayed higher plasma HDL-C concentrations ( P=0.021 ) and lower triglycerides ( P=0.020 ) compared with homozygous for the major allele (GG). In contrast, in the Low fat intervention group no significant differences were found between CETP genotypes after 12 months of dietary treatment. Conclusions: Our data support the notion that a chronic consumption of a Mediterranean diet may play a contributing role in triggering lipid metabolism by interacting with the rs3764261 SNP at CETP gene locus in MetS patients

scholarly journals Cost-effectiveness of an early intervention service for people with psychosis

2010 ◽  
Vol 196 (5) ◽  
pp. 377-382 ◽  
Author(s):  
Paul McCrone ◽  
Tom K. J. Craig ◽  
Paddy Power ◽  
Philippa A. Garety
Keyword(s):  
Quality Of Life ◽  
Early Intervention ◽  
Cost Effectiveness ◽  
Standard Care ◽  
Intervention Group ◽  
Cost Effective ◽  
Care Group ◽  
Early Intervention Service ◽  
Intervention Service

BackgroundThere is concern that delaying treatment for psychosis may have a negative impact on its long-term course. A number of countries have developed early intervention teams but there is limited evidence regarding their cost-effectiveness.AimsTo compare the costs and cost-effectiveness of an early intervention service in London with standard care.MethodIndividuals in their first episode of psychosis (or those who had previously discontinued treatment) were recruited to the study. Clinical variables and costs were measured at baseline and then at 6- and 18-month follow-up. Information on quality of life and vocational outcomes were combined with costs to assess cost-effectiveness.ResultsA total of 144 people were randomised. Total mean costs were £11 685 in the early intervention group and £14 062 in the standard care group, with the difference not being significant (95% CI –£8128 to £3326). When costs were combined with improved vocational and quality of life outcomes it was shown that early intervention would have a very high likelihood of being cost-effective.ConclusionsEarly intervention did not increase costs and was highly likely to be cost-effective when compared with standard care.

scholarly journals Effect of a Mediterranean Diet Intervention on Dietary Glycemic Load and Dietary Glycemic Index: The PREDIMED Study

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Ana Isabel Rodríguez-Rejón ◽  
Itandehui Castro-Quezada ◽  
Cristina Ruano-Rodríguez ◽  
María Dolores Ruiz-López ◽  
Almudena Sánchez-Villegas ◽  
...  
Keyword(s):  
Dietary Intervention ◽  
Linear Models ◽  
Glycemic Load ◽  
Virgin Olive Oil ◽  
Intervention Group ◽  
Extra Virgin Olive Oil ◽  
Control Group ◽  
Inverse Association ◽  
Year Effect ◽  
One Year

Objective. To compare the one year effect of two dietary interventions with MeDiet on GL and GI in the PREDIMED trial.Methods. Participants were older subjects at high risk for cardiovascular disease. This analysis included 2866 nondiabetic subjects. Diet was assessed with a validated 137-item food frequency questionnaire (FFQ). The GI of each FFQ item was assigned by a 5-step methodology using the International Tables of GI and GL Values. Generalized linear models were fitted to assess the relationship between the intervention group and dietary GL and GI at one year of follow-up, using control group as reference.Results. Multivariate-adjusted models showed an inverse association between GL and MeDiet + extra virgin olive oil (EVOO) group:β= −8.52 (95% CI: −10.83 to −6.20) and MeDiet + Nuts group:β= −10.34 (95% CI: −12.69 to −8.00), when comparing with control group. Regarding GI,β= −0.93 (95% CI: −1.38 to −0.49) for MeDiet + EVOO,β= −1.06 (95% CI: −1.51 to −0.62) for MeDiet + Nuts when comparing with control group.Conclusion. Dietary intervention with MeDiet supplemented with EVOO or nuts lowers dietary GL and GI.

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