Impact of Pre-Ramadan Intervention Program on Diabetic Patients (PRINTED 1) : A Randomised Controlled Trial in a Family Medicine Clinic - Abu Dhabi

2019 ◽  
Vol 17 (1) ◽  
pp. 10-22 ◽  
Author(s):  
Osama Moheb Ibrahim Mohamed ◽  
Adnan Syeed ◽  
Fozia. B. Khan
Keyword(s):  
Randomised Controlled Trial ◽  
Family Medicine ◽  
Intervention Program ◽  
Controlled Trial ◽  
Abu Dhabi ◽  
Diabetic Patients ◽  
Medicine Clinic ◽  
Randomised Controlled

scholarly journals International Randomised Controlled Trial evaluating metabolic syndrome in type 2 Diabetic Cigarette Smokers following switching to Combustion-Free Nicotine Delivery Systems: the DIASMOKE protocol

2020 ◽  
Author(s):  
Arkadiusz Krysinski ◽  
Cristina Russo ◽  
Sarah John ◽  
Jonathan Belsey ◽  
Davide Campagna ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Health Impact ◽  
Diabetic Patients ◽  
Cigarette Smokers ◽  
Nicotine Delivery ◽  
Randomised Controlled ◽  
Type 2 Diabetic

Reducing exposure to cigarette smoke is an imperative for public health, and even more so for diabetic patients. Increasingly, combustion-free technologies for nicotine delivery such as e-cigarettes and heated tobacco products are substituting conventional cigarettes and accelerating the current downward trends in smoking prevalence. However, there is limited information about the long-term health impact in diabetics who use these technologies. This international randomised controlled trial of type 2 diabetic cigarette smokers will test the hypothesis that following a switch from conventional cigarettes to Combustion-Free Nicotine Delivery Systems (C-F NDS), a measurable improvement in metabolic syndrome (MetS) risk factors and functional parameters will be shown over the course of 2 years. A total of 576 patients will be randomized (1:2 ratio) to either a control arm (Study Arm A), in which they will be offered referral to smoking cessation programs or to an intervention arm (Study Arm B), in which they will be assigned to C-F NDS use. The primary outcome will be the prevalence of the a difference in MetS score between baseline and 2 years follow-up, with comparison being made between diabetic patients randomized to each arm of the study. Patient recruitment will start in October 2020 and enrolment is expected to be completed by August 2021. This will be the first study determining the overall health impact of using such technologies in diabetic patients. Data from this study will provide valuable insights into the overall potential of C-F NDS to reduce the risk of cardiovascular disease in individuals, particularly diabetic patients. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04231838

scholarly journals WeChat-based intervention to support breastfeeding for Chinese mothers: protocol of a randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Li Tang ◽  
Andy H. Lee ◽  
Colin W. Binns ◽  
Lian Duan ◽  
Yi Liu ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Exclusive Breastfeeding ◽  
Intervention Program ◽  
Controlled Trial ◽  
Control Group ◽  
Worst Case ◽  
Breastfeeding Rate ◽  
Maternity Hospitals ◽  
Breastfeeding Rates ◽  
Randomised Controlled

Abstract Background Exclusive breastfeeding for the first 6 months of life is the optimal way to feed infants. However, recent studies suggest that exclusive breastfeeding rates in China remain low and are well below the recommended target. There has been evidence that a lack of awareness of, or exposure to, breastfeeding information is associated with poor breastfeeding practices. WeChat, the most widely used social networking platform in China, has shown some potential to promote health behaviours. We thus hypothesised that a breastfeeding intervention program delivered via WeChat would achieve at least a 10% increase in exclusive breastfeeding prevalence at 6 months compared to the control group. Methods A two-arm, parallel, multicentre randomised controlled trial of 1000 pregnant women will be conducted at four maternity hospitals of Chengdu, China. Eligible women who consent to participate in the trial will be recruited at 28–30 weeks of gestation, and randomly allocated to either the intervention group (participants receive breastfeeding-related information from WeChat) or the control group (participants receive non-breastfeeding information from WeChat) using a central randomisation system on a 1:1 ratio at each participating site. The primary outcomes are exclusive breastfeeding rate and full breastfeeding rate at 6 months postpartum. All randomised participants will be included in the outcome analyses with missing data being imputed based on the best-case and worst-case scenarios. Multilevel mixed regression models will be used in the primary analyses to assess the effectiveness of intervention program on the breastfeeding rates. Discussion This trial uses the most widely used social media program as a means of delivering messages to mothers to increase exclusive breastfeeding in China. Increasing exclusive breastfeeding will contribute to meeting the health and environmental goals of the Sustainable Development Guidelines. Trial registration ClinicalTrials.gov, NCT04499404. Registered 5 August 2020—Retrospectively registered, https://clinicaltrials.gov/show/NCT04499404

scholarly journals Accelerometer-based facilitated walking program in addition to usual care for the management of patients with low back pain at medium or high risk of chronicity: a randomised controlled trial protocol

2019 ◽  
Vol 6 (1) ◽  
pp. 23
Author(s):  
Hosam Alzahrani ◽  
Martin Mackey ◽  
Emmanuel Stamatakis ◽  
Marina B. Pinheiro ◽  
Debra Shirley
Keyword(s):  
Physical Activity ◽  
Low Back Pain ◽  
Back Pain ◽  
High Risk ◽  
Randomised Controlled Trial ◽  
Intervention Program ◽  
Controlled Trial ◽  
Low Back ◽  
Walking Intervention ◽  
Randomised Controlled

<p> </p><p class="abstract"><strong>Background:</strong> The lifetime prevalence of low back pain (LBP) has been reported to be as high as 84% worldwide. Around 23% of the population has chronic non-specific LBP. Despite the potential health benefits of walking, few studies have investigated its effectiveness in people with non-specific LBP. The primary objective is to examine the efficacy of a Fitbit facilitated walking intervention in people with LBP with medium or high risk of chronicity in reducing disability and pain. The secondary objective is to investigate the efficacy of a Fitbit facilitated walking intervention in increasing physical activity levels in people with LBP.</p><p class="abstract"><strong>Methods:</strong> This prospective, randomised controlled trial<strong> </strong>will involve 68 participants. This study will recruit participants who are aged 18 years or over, have been diagnosed with non-specific LBP with medium or high risk of chronicity and classified as physically inactive. Participants will be randomised into two groups: usual physiotherapy care (n=34) and usual physiotherapy care plus Fitbit facilitated walking intervention program (n=34). The treatment duration will be 8 weeks. Primary outcomes for this study are disability and pain. Secondary outcomes include physical activity level and walking steps, depression, fear of movement and pain catastrophising. The outcomes will be assessed at baseline, post-intervention and 26 weeks post-randomisation follow-up.</p><p class="abstract"><strong>Conclusions:</strong> The results of this study will provide empirical evidence on the efficacy of a Fitbit facilitated walking intervention program, when added to usual care, in a clinical setting for improving disability and pain, and other clinical outcomes in people with LBP.</p><p class="abstract"><strong>Trial Registration: </strong>Australian New Zealand clinical trials registry (Number ACTRN12617001404314).</p>

scholarly journals Nephroprotective Impact of Adjuvant Yoga Therapy on Diabetes- A Randomised Controlled Trial

2020 ◽  
Author(s):  
Rajasekar Balaji ◽  
Meena Ramanathan ◽  
Ananda Balayogi Bhavanani
Keyword(s):  
Randomised Controlled Trial ◽  
Blood Sugar ◽  
Medical Management ◽  
Metabolic Diseases ◽  
Controlled Trial ◽  
Control Group ◽  
Diabetic Patients ◽  
Yoga Therapy ◽  
Yoga Group ◽  
Randomised Controlled

Introduction: Recent studies have provided abundant evidence about benefits of yoga in various chronic disorders. Diabetes Mellitus (DM) is a group of metabolic diseases characterised by chronic hyperglycaemia and renal complications of the disease are especially notable. It is estimated that 10% to 40% cases of Type 2 DM (T2DM) eventually end up having kidney failure. Yoga therapy may help to prevent progression of kidney damage in diabetic patients. Aim: To evaluate the effect of adjuvant yoga therapy on renal profile in diabetic patients. Materials and Methods: This single blind Randomised Controlled Trial (RCT) was designed as an interdisciplinary collaborative work between Centre for Yoga Therapy, Education and Research (CYTER) and Department of Endocrinology of Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth, Puducherry, India. A total of 72 diabetic patients with HbA1c, more than 7% were recruited and pre study evaluation of Fasting Blood Sugar (FBS), Postprandial Blood Sugar (PPBS), HbA1c, blood urea and serum creatinine were done. They were then randomised into control group (n=36) who received only standard medical management and yoga group (n=36) who received yoga therapy thrice weekly for 4 months along with standard medical management. Poststudy evaluation of all parameters was done at end of study period and data were analysed by Student’s paired and unpaired t-test for intra and intergroup comparisons. Results: Postinterventional comparisons revealed statistically significant reductions (p<0.001) in all glycaemic and renal parameters in the group receiving yoga therapy when compared with control group who didn’t receive the yoga intervention. Intragroup comparisons revealed significant reduction of all parameters in yoga group. Conclusion: It is concluded from the present RCT that yoga has a definite role as an adjuvant therapy as it enhances standard medical care and hence, can be recommended in routine clinical management of diabetes to prevent progression into complications that are part of the natural history of the disease.

scholarly journals Effects of a foot-ankle strengthening programme on clinical aspects and gait biomechanics in people with knee osteoarthritis: protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e039279
Author(s):  
Glauko Dantas ◽  
Isabel C N Sacco ◽  
Ana F dos Santos ◽  
Ricky Watari ◽  
Alessandra B Matias ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Knee Joint ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Clinical Aspects ◽  
Control Group ◽  
Diabetic Patients ◽  
Foot Kinematics ◽  
Medication Intake ◽  
Randomised Controlled

IntroductionStudies have indicated that hip and knee muscle strengthening are effective in reducing pain, improving self-reported function and increasing lower limb strength, without, however, decreasing knee joint overload during gait in patients with knee osteoarthritis (KOA). Recent research has shown that strengthening the foot-ankle muscles improved function in diabetic patients and reduced patellofemoral pain. The aim of this paper is to investigate whether an 8-week therapeutic foot-ankle exercise programme improves pain, functionality, foot strength, foot kinematics and knee joint overload during gait, and decreases medication intake in individuals with KOA.Methods and analysisThis two-arm, prospectively registered, randomised controlled trial with blinded assessors will involve 88 patients with medial tibiofemoral osteoarthritis. Subjects will be randomly allocated to a control group that will receive no specific foot intervention and will follow treatment recommended by the medical team; or an intervention group that will undergo an 8-week physiotherapist-supervised strengthening programme for extrinsic and intrinsic foot muscles, three times a week. The primary outcome will be the pain domain of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). The secondary outcomes include WOMAC stiffness and function domains, total WOMAC score, physical function, foot muscle isometric strength, foot kinematics and knee kinetics during gait, and medication intake. Data will be analysed on intention-to-treat principles and a per protocol basis.Ethics and disseminationInvestigators and sponsors will communicate trial results to participants and healthcare professionals through scientific databases and social media. In addition, findings will be reported in peer-review publications, and at national and international conference presentations. Ethics approval: Ethics Committee of the Universidade Federal de São Carlos, São Carlos, SP, Brazil (N° 3.488.466).Trial registration numberNCT04154059.

Sign in / Sign up

Export Citation Format

Share Document