The effect of the Original MethOd at pharmacy To ENhAnce Support for Health Improvement in the limited Japanese proficiency patients visiting local community pharmacy: A randomized controlled trial

Author(s):  
Shota Suzuki ◽  
Eri Toda Kato ◽  
Keiko Sato ◽  
Manako Konda ◽  
Yoshihiro Kuwabara ◽  
...  
Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Klajdi Puka ◽  
Karen Bax ◽  
Andrea Andrade ◽  
Margo Devries-Rizzo ◽  
Hema Gangam ◽  
...  

Abstract Background Epilepsy extends far beyond seizures; up to 80% of children with epilepsy (CWE) may have comorbid cognitive or mental health problems, and up to 50% of parents of CWE are at risk for major depression. Past research has also shown that family environment has a greater influence on children’s and parents’ health-related quality of life (HRQOL) and mental health than epilepsy-related factors. There is a pressing need for low-cost, innovative interventions to improve HRQOL and mental health for CWE and their parents. The aim of this randomized controlled trial (RCT) is to evaluate whether an interactive online mindfulness-based intervention program, Making Mindfulness Matter (M3), can be feasibly implemented and whether it positively affects CWE’s and parents’ HRQOL and mental health (specifically, stress, behavioral, depressive, and anxiety symptoms). Methods This parallel RCT was planned to recruit 100 child-parent dyads to be randomized 1:1 to the 8-week intervention or waitlist control and followed over 20 weeks. The intervention, M3, will be delivered online and separately to parents and children (ages 4–10 years) in groups of 4–8 by non-clinician staff of a local community epilepsy agency. The intervention incorporates mindful awareness, social-emotional learning skills, and positive psychology. It is modeled after the validated school-based MindUP program and adapted for provision online and to include a parent component. Discussion This RCT will determine whether this online mindfulness-based intervention is feasible and effective for CWE and their parents. The proposed intervention may be an ideal vector to significantly improve HRQOL and mental health for CWE and their parents given its low cost and implementation by community epilepsy agencies. Trial registration ClinicalTrials.gov NCT04020484. Registered on July 16, 2019. 


2017 ◽  
Vol 27 (2) ◽  
pp. 841-855 ◽  
Author(s):  
Daniel Bressington ◽  
Wai Tong Chien ◽  
Jolene Mui ◽  
Kar Kei Claire Lam ◽  
Ziyad Mahfoud ◽  
...  

2019 ◽  
Vol 287 ◽  
pp. e181
Author(s):  
K. Svendsen ◽  
D.R. Jacobs ◽  
L.T. Mørch-Reiersen ◽  
K.W. Garstad ◽  
V.T. Telle-Hansen ◽  
...  

Author(s):  
Ciera L Bartholomew ◽  
Joseph B Muhlestein ◽  
Heidi T May ◽  
Viet T Le ◽  
Oxana Galenko ◽  
...  

Abstract Background Low-density lipoprotein cholesterol (LDL-C) predicts heart disease onset and may be reduced by intermittent fasting. Some studies, though, reported that fasting increased LDL-C; however, no study evaluated LDL-C as the primary endpoint. This randomized controlled trial evaluated the effect of low-frequency intermittent fasting on LDL-C and other biomarkers. Methods Adults ages 21-70 years were enrolled who were not taking a statin, had modestly elevated LDL-C, had ≥1 metabolic syndrome feature or type 2 diabetes, and were not taking anti-diabetic medication (N = 103). Water-only 24-hour fasting was performed twice-weekly for 4 weeks, then once-weekly for 22 weeks; controls ate ad libitum. The primary outcome was 26-week LDL-C change score. Secondary outcomes (requiring p ≤ 0.01) were 26-week changes in homeostatic model assessment of insulin resistance (HOMA-IR), Metabolic Syndrome Score (MSS), brain-derived neurotrophic factor (BDNF), and MicroCog general cognitive proficiency index (GCPi). Results Intermittent fasting (n = 50) and control (n = 53) subjects were, respectively, aged 49.3±12.0 and 47.0±9.8 years, predominantly female (66.0% & 67.9%), overweight (103±24 & 100±21 kg), and had modest LDL-C elevation (124±19 & 128±20 mg/dL). Drop-outs (n = 12 fasting, n = 20 control) provided an evaluable sample of n = 71 (n = 38 fasting, n = 33 control). Intermittent fasting did not change LDL-C (0.2±16.7 mg/dL) versus control (2.5±19.4 mg/dL; p = 0.59), but it improved HOMA-IR (-0.75±0.79 vs. -0.10±1.06; p = 0.004) and MSS (-0.34±4.72 vs. 0.31±1.98, p = 0.006). BDNF (p = 0.58), GCPi (p = 0.17), and weight (-1.7±4.7 kg vs. 0.2±3.5 kg, p = 0.06) were unchanged. Conclusions A low-frequency intermittent fasting regimen did not reduce LDL-C or improve cognitive function, but significantly reduced both HOMA-IR and MSS. Trial registration clinicaltrials.gov, NCT02770313


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