scholarly journals Nutritional support for lactating women with or without Azithromycin for infants compared to breast-feeding counselling alone, to improve six-month growth outcomes among infants of peri-urban slums of Karachi, Pakistan – a protocol of multi-arm assessor blinded randomized controlled trial (Mumta LW trial)

2020 ◽  
Author(s):  
Ameer Muhammad ◽  
Yasir Shafiq ◽  
M Imran Nisar ◽  
Benazir Baloch ◽  
Amna Tanweer Yazdani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Controlled Trial ◽  
Intervention Group ◽  
Relative Length ◽  
Trial Registration ◽  
Control Group ◽  
Lactating Women ◽  
Randomized Controlled ◽  
Increased Risk

Abstract BackgroundGlobally, 45% of under-five deaths are, directly or indirectly, attributable to malnutrition, most of these deaths are in low- and middle-income countries (LMICs). Children in the first 6 months of life are particularly vulnerable. An estimated 4.7 million infants under the age of 6 months are moderately wasted whereas 3.8 million are severely wasted. Despite the increased risk to a child of a mother with nutritional decompensation, there are discrepancies in guidance in this area. MethodsThis is a community-based, open-label factorial randomized controlled trial, using parallel assignment with 1:1:1 allocation ratio, in low-income squatter settlements of urban Karachi, Pakistan. In the control group (Arm A), women are randomized to standard counseling only; whereas in the first intervention group (Arm B), lactating women receive two sachets of balanced energy-protein (BEP) supplementation per day from enrollment till the infant reaches six months of age, in the second intervention group (Arm C), lactating women receive same BEP as in intervention Arm B while their babies also receive a single stat dose (20mg/kg orally) of azithromycin at 42 days. The primary outcome is relative length velocity from 0 to 6 months by the limb of allocation. The primary analysis will be Intention-to-treat analysisTrial registrationRegistration of the trial is done at ClinicalTrials.gov. NCT03564652, registered on June 21, 2018. Trial registration data is available through https://clinicaltrials.gov/ct2/show/NCT03564652

scholarly journals Nutritional support for lactating women with or without Azithromycin for infants compared to breast-feeding counselling alone, to improve six-month growth outcomes among infants of peri-urban slums of Karachi, Pakistan – a protocol of multi-arm assessor blinded randomised controlled trial (Mumta LW trial)

2020 ◽  
Author(s):  
Ameer Muhammad ◽  
Yasir Shafiq ◽  
M Imran Nisar ◽  
Benazir Baloch ◽  
Amna Tanweer Yazdani ◽  
...  
Keyword(s):  
Low Income ◽  
Controlled Trial ◽  
Intervention Group ◽  
Relative Length ◽  
Trial Registration ◽  
Control Group ◽  
Primary Analysis ◽  
Open Label ◽  
Lactating Women ◽  
Increased Risk

Abstract Background Globally, 45% of under-five deaths are, directly or indirectly, attributable to malnutrition, most of these deaths are in low- and middle-income countries (LMICs). Children in the first 6 months of life are particularly vulnerable. An estimated 4.7 million infants under the age of 6 months are moderately wasted whereas 3.8 million are severely wasted. Despite an increased risk to a child of a malnourished woman, there are discrepancies in guidance in this area. Methods This is a community-based, open-label multi-arm factorial randomized controlled trial, using parallel assignment with 1:1:1 allocation ratio, in low-income squatter settlements of urban Karachi, Pakistan. In the control group (Control Arm A), women are randomized to standard counseling only; whereas in the first intervention group (Arm BIntervention arm 1), lactating women receive two sachets of balanced energy-protein (BEP) supplementation per day from enrollment till the infant reaches six months of age, in the second intervention group (Arm CIntervention arm 2), lactating women receive same BEP as in intervention Arm B while their babies also receive a single stat dose (20mg/kg orally) of azithromycin at 42 days. The primary outcome is relative length velocity from 0 to 6 months by the limb of allocation. The primary analysis will be Intention-to-treat analysis. Trial registration Registration of the trial is done at ClinicalTrials.gov. NCT03564652, registered on June 21, 2018. Trial registration data is available through https://clinicaltrials.gov/ct2/show/NCT03564652

scholarly journals Nutritional support for lactating women with or without Azithromycin for infants compared to breast-feeding counselling alone, to improve six-month growth outcomes among infants of peri-urban slums of Karachi, Pakistan – a protocol of multi-arm assessor blinded randomised controlled trial (Mumta LW trial)

2020 ◽  
Author(s):  
Ameer Muhammad ◽  
Yasir Shafiq ◽  
M Imran Nisar ◽  
Benazir Baloch ◽  
Amna Tanweer Yazdani ◽  
...  
Keyword(s):  
Low Income ◽  
Controlled Trial ◽  
Intervention Group ◽  
Relative Length ◽  
Trial Registration ◽  
Primary Analysis ◽  
Open Label ◽  
Middle Income ◽  
Lactating Women ◽  
Increased Risk

Abstract Introduction Globally, 45% of under-five deaths are, directly or indirectly, attributable to malnutrition, most of these deaths are in low- and middle-income countries (LMICs). Children in the first 6 months of life are particularly vulnerable. An estimated 4.7 million infants under the age of 6 months are moderately wasted whereas 3.8 million are severely wasted. Despite the increased risk to a child in a mother with nutritional decompensation, there are discrepancies in guidance in this area. Methods and analysis This is a community-based, open label factorial randomized controlled trial, using parallel assignment with 1:1:1 allocation ratio, in low income squatter settlements of urban Karachi, Pakistan. In the controls (Arm 1), women are randomized to standard counseling only; in first intervention group (Arm 2), lactating women receive two sachets of balanced energy-protein (BEP) supplementation per day from delivery until the infant reaches six months of age. In second intervention group (Arm 3), lactating women receive same BEP as in intervention arm 1 and their babies receive single dose (20mg/kg orally) of azithromycin at 42 days. The primary outcome is relative length velocity from 0 to 6 months by limb of allocation. Primary analysis will be Intention-to-treat analysis Trial registration This trial was registered at ClinicalTrials.gov with the number NCT03564652 on June 21, 2018. The trial registration data are available through https://clinicaltrials.gov/ct2/show/NCT03564652.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Japanese health and safety information for overseas visitors: protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mariko Nishikawa ◽  
Masaaki Yamanaka ◽  
Akira Shibanuma ◽  
Junko Kiriya ◽  
Masamine Jimba
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Safety Information ◽  
Intervention Group ◽  
Health And Safety ◽  
Trial Registration ◽  
Control Group ◽  
Internet Portal ◽  
Randomized Controlled

Abstract Background Before the COVID-19 pandemic occurred in January 2020, the number of overseas visitors to Japan had increased threefold over the last decade. To minimize the risk of health problems, visitors should be able to access information on the health care systems of the places they visit. Most short-term overseas visitors are young adults. Although they are not very likely to get sick from noncommunicable diseases, they are at high risk for injury and often experience stomach ailments, fever, or nausea when travelling. The objective of this study is to evaluate culturally and linguistically appropriate health information on preventive health behaviours and the health care system in Japan. We will examine the level of satisfaction of overseas visitors to Japan with health care-related educational materials using a five-minute digital game named Sa-Chan Japan. Methods Our study is a randomized controlled trial (RCT). We will assess both satisfaction and motivation before, during, and after the interventions and examine the changes over time. The intervention group will comprise overseas visitors who will view and answer questions in an animation named Sa-Chan Japan. The control group will comprise overseas visitors who will watch an English digital animation named Mari Info Japan. We will recruit 1002 participants through the Macromill Internet portal. We will contact overseas visitors who have either visited or wish to visit Japan from the United Kingdom, United States, and Australia. The participants will fill out a self-administered questionnaire online in the first quarter of 2021. We will determine the participants’ levels of satisfaction with the CSQ-8 (8-item Client Satisfaction Questionnaire). We will analyse the median score of the overseas visitors with both the Wilcoxon rank-sum and the Wilcoxon signed-rank tests. Our protocol of randomized controlled trials follows the SPIRIT guidelines. Discussion Our research will utilize unique digital education strategies in a game that promotes health and safety among overseas visitors to Japan. We believe the results of this study will be useful in overcoming the current challenges regarding pretravel health requirements for overseas visitors worldwide. Trial registration Version 1 of this trial was registered in the UMIN-CTR (University Hospital Medical Information Network Center Clinical Trials Registry), and the trial registration data are available on UMIN000042483, November 17, 2020.

scholarly journals Traffic-light labels and financial incentives to reduce sugar-sweetened beverage purchases by low-income Latino families: a randomized controlled trial

2018 ◽  
Vol 21 (8) ◽  
pp. 1426-1434 ◽  
Author(s):  
Rebecca L Franckle ◽  
Douglas E Levy ◽  
Lorena Macias-Navarro ◽  
Eric B Rimm ◽  
Anne N Thorndike
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Financial Incentives ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Traffic Light ◽  
Sugar Sweetened Beverages ◽  
Randomized Controlled ◽  
Sweetened Beverages

AbstractObjectiveThe objective of the present study was to test the effectiveness of financial incentives and traffic-light labels to reduce purchases of sugar-sweetened beverages in a community supermarket.DesignIn this randomized controlled trial, after a 2-month baseline period (February–March 2014), in-store traffic-light labels were posted to indicate healthy (green), less healthy (yellow) or unhealthy (red) beverages. During the subsequent five months (April–August 2014), participants in the intervention arm were eligible to earn a $US 25 in-store gift card each month they refrained from purchasing red-labelled beverages.SettingUrban supermarket in Chelsea, MA, USA, a low-income Latino community.SubjectsParticipants were customers of this supermarket who had at least one child living at home. A total of 148 customers (n 77 in the intervention group and n 71 in the control group) were included in the final analyses.ResultsOutcomes were monthly in-store purchases tracked using a store loyalty card and self-reported consumption of red-labelled beverages. Compared with control participants, the proportion of intervention participants who purchased any red-labelled beverages decreased by 9 % more per month (P=0·002). More intervention than control participants reduced their consumption of red-labelled beverages (−23 % v. −2 % for consuming ≥1 red beverage/week, P=0·01).ConclusionsOverall, financial incentives paired with in-store traffic-light labels modestly reduced purchase and consumption of sugar-sweetened beverages by customers of a community supermarket.

scholarly journals Effects of a Mobile App Called Quittr, Which Utilizes Premium Currency and Games Features, on Improving Engagement With Smoking Cessation Intervention: Pilot Randomized Controlled Trial

10.2196/23734 ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. e23734
Author(s):  
Ivan Bindoff ◽  
Tristan R Ling ◽  
Peter Gee ◽  
Benjamin Geelan ◽  
Stuart G Ferguson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Trial Registration ◽  
Control Group ◽  
Randomized Controlled ◽  
Cessation Intervention ◽  
Quit Rate ◽  
Mhealth Apps

Background Numerous mobile health (mHealth) apps have been developed to support smokers attempting to quit smoking. Although these apps have been reported to be successful, only modest improvements in the quit rate have been measured. It has been proposed that efforts to improve user engagement and retention may improve the quit rate further. Owing to the high cost of smoking-related disease, it is considered worthwhile to pursue even small improvements. Objective The aim of this study was to test a novel smartphone app that leverages premium currency strategies developed by the mobile games industry in an attempt to improve engagement and retention with a smoking cessation intervention. Methods We designed and developed a smoking cessation app called “Quittr” in line with previously developed smoking cessation mHealth apps. In addition to this established framework, we added a stand-alone fully featured city-building clicker-style game called “Tappy Town,” and a premium virtual currency called “QuitCoins.” The user earns QuitCoins for using the app in a way that contributes positively toward their quit attempt, and they can redeem these coins in Tappy Town for bonuses. To establish whether these features improved engagement and retention, we ran a 5-month randomized controlled trial where the intervention group had the full app with the extra games features, while the control group had the standard app only. Recruitment was performed via web-based advertising. Participants (N=175) had no direct contact with the researchers or other support staff. Results No significant differences in terms of engagement, retention, or smoking outcomes were found between the control and intervention groups. However, survey data indicated that the majority of the participants valued Tappy Town (10/17, 59%) and the QuitCoins rewards system (13/17, 77%). Usage data also suggested that Tappy Town was widely played and was generally appealing to users (mean total time spent in app, control group: 797 seconds vs intervention group: 3502 seconds, P<.001). Analysis of the results suggests that users in the intervention group may have been negatively affected by the aspects of the chosen design, and some theories were explored to explain this unexpected outcome. Conclusions Although the novel features of the Quittr app failed to improve the key outcomes measured in this study, there were enough positive indications to warrant further exploration of the concept. Additional research will be required to identify and correct any design flaws that may have adversely affected our participants before a follow-up study can be completed. Trial Registration Australian and New Zealand Clinical Trials Register ACTRN12617000491369; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372661&isReview=true

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

scholarly journals Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Keivan Ranjbar ◽  
Mohsen Moghadami ◽  
Alireza Mirahmadizadeh ◽  
Mohammad Javad Fallahi ◽  
Vahid Khaloo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Status ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Ordinal Scale ◽  
Control Group ◽  
Randomized Controlled ◽  
Group Data ◽  
Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

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