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Effects of a Comprehensive Dietary Intervention Program, Promoting Nutrition Literacy, Eating Behavior, Dietary Quality, and Gestational Weight Gain in Chinese Urban Women with Normal Body Mass Index during Pregnancy.
Li, Q, Piaseu, N, Phumonsakul, S, Thadakant, S
Nutrients. 2024;(2)
Abstract
In urban Chinese women with normal body weight during pregnancy, we implemented a comprehensive dietary intervention program aimed at enhancing nutrition literacy, dietary quality, and gestational weight gain. The methods included both online and offline health education on prenatal nutrition, weekly weight monitoring, family back education practices, and real-time dietary guidance. The intervention was delivered to randomly assigned control and intervention group participants from gestational week 12 to week 24. The intervention group (n = 44; 100% complete data) showed significant differences (mean (SD)) compared to the control group (n = 42; 95.5% complete data) in nutrition literacy (53.39 ± 6.60 vs. 43.55 ± 9.58, p < 0.001), restrained eating (31.61 ± 7.28 vs. 28.79 ± 7.96, p < 0.001), Diet Quality Distance (29.11 ± 8.52 vs. 40.71 ± 7.39, p < 0.001), and weight gain within the first 12 weeks of intervention (4.97 ± 1.33 vs. 5.98 ± 2.78, p = 0.029). However, there was no significant difference in the incidence of gestational diabetes (2 (4.5%) vs. 4 (9.5%), p = 0.629). Participants in the intervention group reported an overall satisfaction score of 4.70 ± 0.46 for the intervention strategy. These results emphasize the positive role of comprehensive dietary intervention in promoting a healthy diet during pregnancy.
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Mothers' experiences of a lifestyle intervention for weight reduction 12 months after gestational diabetes mellitus: Qualitative findings from the PAIGE2 study.
Kemp, BJ, Creighton, RM, Cupples, G, Kelly, B, McAuley, E, Fleck, O, Wallace, H, Graham, U, McCance, DR
Midwifery. 2024;:103911
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The standardised pooled prevalence of gestational diabetes mellitus (GDM) globally is approximately 14 %, a reflection of increasing rates of obesity in women of childbearing age. Lifestyle interventions to reduce GDM and subsequent type 2 diabetes (T2D) have been deemed a research priority but are challenging to perform and have variable success rates. The PAIGE2 study was a pragmatic lifestyle randomised controlled trial for women with GDM and body mass index ≥25 kg/m2, which began during pregnancy and continued for one year postnatally. The primary outcome was weight loss 12 months postnatally compared with mothers receiving standard maternity care. Qualitative results are presented from end of study focus groups conducted amongst intervention mothers to gather feedback and determine acceptability of the PAIGE2 intervention. In total, 19 mothers participated in five virtual focus groups. Content analysis explored general study experience, longer term changes to lifestyle and suggested improvements of intervention components including monthly phone calls, motivational text messages, Fitbit experience, Slimming World, and study contact timings. Overall, most mothers found the individual PAIGE2 intervention components enjoyable, although opinions differed as to which were the most effective. Several mothers claimed the intervention helped them make long-term changes to their behaviours. A common suggested improvement was the establishment of a local group where mothers could share their experiences. In conclusion, most mothers deemed the intervention acceptable, and felt that with minor enhancements, it could be utilised as an effective tool to support weight loss after pregnancy and reduce future risk of obesity and T2D.
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Sacral Neuromodulation Versus Conservative Treatment for Refractory Idiopathic Slow-transit Constipation: The Randomized Clinical No.2-Trial.
Heemskerk, SCM, Dirksen, CD, van Kuijk, SMJ, Benninga, MA, Baeten, CIM, Masclee, AAM, Melenhorst, J, Breukink, SO
Annals of surgery. 2024;(5):746-754
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OBJECTIVE Assess the effectiveness of sacral neuromodulation (SNM) versus personalized conservative treatment (PCT) in patients with refractory idiopathic slow-transit constipation (STC). BACKGROUND Evidence on SNM for idiopathic STC is conflicting and of suboptimal methodological quality. METHODS The No.2-Trial was a multicenter, open-label, pragmatic, randomized trial performed in 2 Dutch hospitals. Sixty-seven patients with idiopathic STC, a defecation frequency <3 per week and refractory (ie, unresponsive) to maximal conservative (nonoperative) treatment were included. Exclusion criteria included outlet obstruction, rectal prolapse, and previous colon surgery. Patients were randomized (3:2) to SNM (n=41) or PCT (n=26) with randomization minimization between February 21, 2017 and March 12, 2020. In SNM patients, an implantable pulse generator was implanted after a successful 4-week test stimulation. PCT patients received conservative treatment such as laxatives or retrograde colonic irrigation. The primary outcome was treatment success (defined as average defecation frequency ≥3 per week) after 6 months. Secondary outcomes included constipation severity, fatigue, quality of life, and adverse events. Analysis was according to intention-to-treat. RESULTS After 6 months, 22 (53.7%) patients were successfully treated with SNM versus 1 (3.8%) patient with PCT (odds ratio 36.4, 95% CI 3.4-387.5, P =0.003). At 6 months, SNM patients reported lower constipation severity and fatigue scores ( P <0.001) and improved quality of life compared with PCT ( P <0.001). Eight serious adverse events (6 SNM, 2 PCT) and 78 adverse events (68 SNM, 10 PCT) were reported. CONCLUSIONS SNM is a promising surgical treatment option in a homogeneous group of adults and adolescents with refractory idiopathic STC. No.2-Trial registered at ClinicalTrials.gov NCT02961582.
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Subsidized gestational diabetes mellitus screening and management program in rural China: a pragmatic multicenter, randomized controlled trial.
Xu, T, Xia, Q, Lai, X, He, K, Fan, D, Ma, L, Fang, H
BMC medicine. 2024;(1):98
Abstract
BACKGROUND The increasing prevalence of gestational diabetes mellitus (GDM) is a major challenge, particularly in rural areas of China where control rates are suboptimal. This study aimed to evaluate the effectiveness of a GDM subsidy program in promoting GDM screening and management in these underserved regions. METHODS This multicenter, randomized controlled trial (RCT) was conducted in obstetric clinics of six rural hospitals located in three provinces in China. Eligible participants were pregnant women in 24-28 weeks' gestation, without overt diabetes, with a singleton pregnancy, access to a telephone, and provided informed consent. Participants were randomly assigned in a 1:1 ratio to either the intervention or control groups using an internet-based, computer-generated randomization system. The intervention group received subsidized care for GDM, which included screening, blood glucose retesting, and lifestyle management, with financial assistance provided to health care providers. In contrast, the control group received usual care. The primary outcomes of this study were the combined maternal and neonatal complications associated with GDM, as defined by the occurrence of at least one pre-defined complication in either the mother or newborn. The secondary outcomes included the GDM screening rate, rates of glucose retesting for pregnant women diagnosed with GDM, dietary patterns, physical activity levels, gestational weight gain, and antenatal visit frequency for exploratory purposes. Primary and secondary outcomes were obtained for all participants with and without GDM. Binary outcomes were analyzed by the generalized linear model with a link of logistic, and odds ratios (OR) with 95% confidence intervals (CIs) were reported. Count outcomes were analyzed by Poisson regression, and incidence rate ratios with 95% CIs were reported. RESULTS A total of 3294 pregnant women were randomly assigned to either the intervention group (n = 1649) or the control group (n = 1645) between 15 September 2018 and 30 September 2019. The proportion of pregnant women in the intervention group who suffered from combined maternal and/or neonatal complications was lower than in the control group with adjusted OR = 0.86 (0.80 to 0.94, P = 0.001), and a more significant difference was observed in the GDM subgroup (adjusted OR = 0.66, 95% CI 0.47 to 0.95, P = 0.025). No predefined safety or adverse events of ketosis or ketoacidosis associated with GDM management were detected in this study. Both the intervention and control groups had high GDM screening rates (intervention: 97.2% [1602/1649]; control: 94.5% [1555/1645], P < 0.001). Moreover, The intervention group showed a healthier lifestyle, with lower energy intake and more walking minutes (P values < 0.05), and more frequent blood glucose testing (1.5 vs. 0.4 visits; P = 0.001) compared to the control group. CONCLUSION In rural China, a GDM care program that provided incentives for both pregnant women and healthcare providers resulted in improved maternal and neonatal health outcomes. Public health subsidy programs in China should consider incorporating GDM screening and management to further enhance reproductive health. TRIAL REGISTRATION China Clinical Trials Registry ChiCTR1800017488. https://www.chictr.org.cn/.
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Home- versus centre-based EXercise InTervention in patients with Heart Failure (EXIT-HF trial): A pragmatic randomized controlled trial.
Schmidt, C, Magalhães, S, Gois Basilio, P, Gouveia, M, Teixeira, M, Santos, C, Tavares, AI, Ferreira, JP, Ribeiro, F, Santos, M
Revista portuguesa de cardiologia : orgao oficial da Sociedade Portuguesa de Cardiologia = Portuguese journal of cardiology : an official journal of the Portuguese Society of Cardiology. 2024;(3):149-158
Abstract
INTRODUCTION The limited accessibility and the lack of adherence explain, in part, the low proportion of heart failure (HF) patients undergoing exercise-based cardiac rehabilitation (CR) programs. Home-based programs showed to be as effective and less costly than centre-based ones and might address those obstacles. Whether the evidence from international studies can be applied to our population is still unclear. OBJECTIVES To compare the clinical and economic impact of a home-based versus centre-based CR intervention in HF patients. METHODS This is a single-center, single-blind, parallel groups, non-inferiority pragmatic randomized control trial. Adult HF patients (n=120) will be randomized to either a centre-based or home-based CR program. In both groups' patients will participate in a 12-week combined CR program with 2 sessions per week. Exercise training (ExT) protocol consists of a combination of endurance [(at 60%-80% of peak oxygen uptake (VO2peak)] and resistance training (elastic bands). Those allocated to the home-based program will start with 4-5 supervised ExT sessions to familiarize themselves with the training protocol and then will continue the remaining sessions at home. The primary endpoint is the change in VO2peak at the end of the 12-week program. Secondary outcomes include alterations in circulating biomarkers, physical fitness, physical activity, quality of life, diet, psychological wellbeing, dyspnea, and cost-effectiveness analyses. RESULTS Patients are currently being recruited for the study. The study started in November 2019 and data collection is anticipated to be completed by December 2022. This is the first study in Portugal comparing the traditional CR program with a home-based program in HF patients. Our study results will better inform healthcare professionals who care for HF patients regarding CR.
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The impact of COVID-19 on a large pragmatic clinical trial embedded in primary care.
Leatherman, SM, Hau, C, Klint, A, Glassman, PA, Taylor, AA, Ferguson, RE, Cushman, WC, Ishani, A
Contemporary clinical trials. 2023;:107179
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INTRODUCTION The COVID-19 pandemic had significant impact on clinical care and clinical trial operations, but the impact on decentralized pragmatic trials is unclear. The Diuretic Comparison Project (DCP) is a Point-of Care (POC) pragmatic trial testing whether chlorthalidone is superior to hydrochlorothiazide in preventing major cardiovascular (CV) events and non-cancer death. DCP utilized telephone consent, data collection from the electronic health record and Medicare, forwent study visits, and limited provider commitment beyond usual care. We assessed the impact of COVID-19 on recruitment, follow-up, data collection, and outcome ascertainment in DCP. METHODS We compared data from two 8-month periods: Pre-Pandemic (July 2019-February 2020) and Mid-Pandemic (July 2020-February 2021). Consent and randomization rates, diuretic adherence, blood pressure (BP) and electrolyte follow-up rates, records of CV events, hospitalization, and death rates were compared. RESULTS Providers participated at a lower rate mid-pandemic (65%) than pre-pandemic (71%), but more patients were contacted (7622 vs. 5363) and consented (3718 vs. 3048) mid-pandemic than pre-pandemic. Patients refilled medications and remained on their randomized diuretic equally (90%) in both periods. Overall, rates of BP, electrolyte measurements, and hospitalizations decreased mid-pandemic while deaths increased. CONCLUSIONS While recruitment, enrollment, and adherence did not suffer during the pandemic, documented blood pressure checks and laboratory evaluations decreased, likely due to fewer in-person visits. VA hospitalizations decreased, despite a considerable number of COVID-related hospitalizations. This suggests changes in clinical care during the pandemic, but the limited impact on DCP's operations during a global pandemic is an important strength of POC trials. CLINICAL TRIAL REGISTRATION NCT02185417.
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Associations between grip strength, cardiorespiratory fitness, cardiovascular risk and mental health in forcibly displaced people from a Greek refugee camp.
Gerber, M, Filippou, K, Knappe, F, Morres, ID, Tzormpatzakis, E, Havas, E, Seelig, H, Colledge, F, Ludyga, S, Meier, M, et al
Scientific reports. 2023;(1):20970
Abstract
Muscular strength represents a specific component of health-related fitness. Hand grip strength is used as a simple and dynamic marker of maximum voluntary force of the hand and to estimate overall strength. Today, little is known about the relationship between grip strength and health in forcibly displaced populations. In the present study, we examined whether grip strength is associated with various health outcomes in a sample of forcibly displaced people living in a Greek refugee camp. The present analyses are part of a larger pragmatic randomized controlled trial. In this paper, cross-sectional baseline data of 143 participants (71 men, 72 women) will be presented. In addition to grip strength, the following physical and mental health outcomes were assessed: body weight and body composition, blood pressure, total cholesterol, low- and high-density lipoprotein cholesterol, triglycerides, blood glucose levels (HbA1c), post-traumatic stress disorder (PTSD) symptoms, depressive and anxiety symptoms, pain, and quality of life. Linear regression analyses were carried out to examine how grip strength is associated with the health outcomes, separately for absolute and normalized grip strength scores. Grip strength was positively and strongly associated with percentage muscle mass (normalized grip strength: Stand. B = 0.58, p < .001), whereas a negative association existed for percentage body fat (normalized grip strength: Stand. B = - 0.58, p < .001). No statistically significant associations occurred between grip strength and the other cardiovascular risk markers. In contrast, we found that participants with higher normalized grip strength reported higher levels of PTSD (normalized grip strength: Stand. B = 0.36, p < .05) and depressive symptoms (normalized grip strength: Stand. B = 0.29, p < .05). No significant association occurred between grip strength, anxiety, pain and quality of life. Measuring grip strength in forcibly displaced people can be a useful way to assess their overall muscle strength. Grip strength tests are easy to implement, and results can be used to assess the effects of specific intervention measures. Nevertheless, our results question the usefulness of grip strength as a marker of cardiovascular health and mental wellbeing in a refugee camp setting.
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Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of <400µ: a cost-effectiveness analysis from the DIAMONDS trial.
Mistry, H, Maredza, M, Campbell, C, Lois, N, ,
BMJ open. 2023;(10):e067684
Abstract
OBJECTIVES To estimate the economic costs, health-related quality-of-life outcomes and cost-effectiveness of subthreshold micropulse laser (SML) versus standard laser (SL) for the treatment of diabetic macular oedema (DMO) with central retinal thickness (CRT) of <400µ. DESIGN An economic evaluation was conducted within a pragmatic, multicentre, randomised clinical trial, DIAbetic Macular Oedema aNd Diode Subthreshold. SETTING 18 UK Hospital Eye Services. PARTICIPANTS Adults with diabetes and centre involving DMO with CRT<400µ. INTERVENTIONS Participants (n=266) were randomised 1:1 to receive SML or SL. METHODS The base-case used an intention-to-treat approach conducted from a UK National Health Service (NHS) and personal social services (PSS) perspective. Costs (2019-2020 prices) were collected prospectively over the 2-year follow-up period. A bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained and the incremental net monetary benefit of SML in comparison to SL. Sensitivity analyses explored uncertainty and heterogeneity in cost-effectiveness estimates. RESULTS One participant in the SL arm withdrew consent for data to be used; data from the remaining 265 participants were included in analyses. Mean (SE) NHS and PSS costs over 24 months were £735.09 (£111.85) in the SML arm vs £1099.70 (£195.40) in the SL arm (p=0.107). Mean (SE) QALY estimates were 1.493 (0.024) vs 1.485 (0.020), respectively (p=0.780), giving an insignificant difference of 0.008 QALYs. The probability SML is cost-effective at a threshold of £20 000 per QALY was 76%. CONCLUSIONS There were no statistically significant differences in EQ-5D-5L scores or costs between SML and SL. Given these findings and the fact that SML does not burn the retina, unlike SL and has equivalent efficacy to SL, it may be preferred for the treatment of people with DMO with CRT<400µ. TRIAL REGISTRATION NUMBERS ISRCTN17742985; NCT03690050.
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Healthcare Costs and Healthcare Utilization Outcomes of Vitamin D3 Supplementation at 5000 IU Daily during a 10.9 Month Observation Period within a Pragmatic Randomized Clinical Trial.
LaRiccia, PJ, Cafaro, T, John, D, van Helmond, N, Mitrev, LV, Bandomer, B, Brobyn, TL, Hunter, K, Roy, S, Ng, KQ, et al
Nutrients. 2023;(20)
Abstract
Vitamin D insufficiency has been linked to multiple conditions including bone disease, respiratory disease, cardiovascular disease, diabetes, and cancer. Observational studies indicate lower healthcare costs and healthcare utilization with sufficient vitamin D levels. The secondary aims of our previously published pragmatic clinical trial of vitamin D3 supplementation were comparisons of healthcare costs and healthcare utilization. Comparisons were made between the vitamin D3 at 5000 IU supplementation group and a non-supplemented control group. Costs of care between the groups differed but were not statistically significant. Vitamin D3 supplementation reduced healthcare utilization in four major categories: hospitalizations for any reason (rate difference: -0.19 per 1000 person-days, 95%-CI: -0.21 to -0.17 per 1000 person-days, p < 0.0001); ICU admissions for any reason (rate difference: -0.06 per 1000 person-days, 95%-CI: -0.08 to -0.04 per 1000 person-days, p < 0.0001); emergency room visits for any reason (rate difference: -0.26 per 1000 person-days, 95%-CI: -0.46 to -0.05 per 1000 person-days, p = 0.0131; and hospitalizations due to COVID-19 (rate difference: -8.47 × 10-3 per 1000 person-days, 95%-CI: -0.02 to -1.05 × 10-3 per 1000 person-days, p = 0.0253). Appropriately powered studies of longer duration are recommended for replication of these utilization findings and analysis of cost differences.
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Clinical application of 4% sodium citrate and heparin in the locking of central venous catheters (excluding dialysis catheters) in intensive care unit patients: A pragmatic randomized controlled trial.
Deng, Y, Xing, J, Tan, Z, Ai, X, Li, Y, Zhang, L
PloS one. 2023;(7):e0288117
Abstract
OBJECTIVES The feasibility of utilizing 4% sodium citrate as an alternative locking solution for central venous catheters (CVCs) (excluding dialysis catheters) was assessed. METHODS Using heparin saline and 4% sodium citrate as locking solution, then 152 patients in ICU undergoing infusion with central venous catheters, were randomly assigned to receive either 10 U/mL heparin saline or 4% sodium citrate. The used outcome indicators include: four indexes of blood coagulation at 10 minutes after locking and 7 d after the first locking, bleeding around the puncture site and subcutaneous hematoma rate, gastrointestinal bleeding rate, catheter indwelling time, catheter occlusion rate, catheter-related bloodstream infection (CRBSI) rate, rate of ionized calcium < 1.0 mmol/L. The main outcome indicator was the activated partial thromboplastin time (APTT) at 10 min after tube locking. The trial was approved by relevant authorities (Chinese Clinical Trial Registry, no: ChiCTR2200056615, registered on February 9, 2022, http://www.chictr.org.cn; Ethics Committee of People's Hospital of Zhongjiang County, no: JLS-2021-034, approved at May 10, 2021, and no: JLS-2022-027, approved at May 30, 2022). RESULTS Among the main outcome measures, the heparin group showed a significant increase in APTT compared to the sodium citrate group at 10 min after locking (LSMD = 8.15, 95%Cl 7.1 to 9.2, P < 0.001). Among the secondary outcome measures, the heparin group demonstrated a significant increase in prothrombin time (PT) compared to the sodium citrate group at 10 minutes after locking (LSMD = 0.86, 95%CI 0.12 to 1.61, P = 0.024). It is found that APTT (LSMD = 8.05, 95%CI 6.71 to 9.4, P < 0.001), PT (LSMD = 0.78, 95%CI 0.14 to 1.42, P = 0.017) and fibrinogen (FB) (LSMD = 1.15, 95%CI 0.23 to 2.08, P = 0.014) at 7 d after locking are increased in the heparin group compared to sodium citrate group. There was no significant difference in catheter indwelling time between the two groups (P = 0.456). The incidence of catheter blockage was lower in sodium citrate group (RR = 0.36, 95%CI 0.15 to 0.87, P = 0.024). No CRBSI occurred in the two groups. Among the safety evaluation indexes, the incidence of bleeding around the puncture site and subcutaneous hematoma was lower in sodium citrate group (RR = 0.1, 95%CI 0.01 to 0.77, P = 0.027). There was no significant difference in the incidence of calcium ion < 1.0 mmol/L between the two groups (P = 0.333). CONCLUSIONS In ICU patients using CVCs (excluding dialysis catheters) infusion, employing 4% sodium citrate as a locking liquid can reduce the risk of bleeding and catheter occlusion without any hypocalcemia.