scholarly journals Importance of Active Participation in Obesity Management Through Mobile Health Care Programs: Substudy of a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Bumjo Oh ◽  
Ga-Hye Yi ◽  
Min Kyu Han ◽  
Jong Seung Kim ◽  
Chang Hee Lee ◽  
...  
Keyword(s):  
Weight Loss ◽  
Controlled Trial ◽  
Intervention Group ◽  
Active Participation ◽  
Control Group ◽  
Body Fat Percentage ◽  
Fat Percentage ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Passive Group

BACKGROUND Due to the prevalence of the westernized dietary pattern and lack of physical activity, the numbers of overweight or obese individuals are increasing, resulting in a growing health burden because of various related diseases. A lifestyle modification approach has additional advantages compared with pharmacological therapies or bariatric surgery. In our randomized controlled trial conducted in 2015, we successfully used a ubiquitous health care (SmartCare) service for patients with metabolic syndrome to achieve a significant weight loss effect. Various useful apps have been developed for the SmartCare Service, which involves using a mobile phone to manage chronic diseases, minimizing time and space restrictions. Many studies have demonstrated weight loss effects using a SmartCare service, but limited data are available regarding the effect of active participation in relation to weight loss. OBJECTIVE We aimed to assess the weight loss effect achieved after using the SmartCare service in terms of adherence and participation. We divided the intervention group of the previous study according to participation level, and analyzed whether there was a significant difference in the outcome. METHODS We classified participants into 3 groups according to their adherence. Within the intervention group using the SmartCare service, the active group comprised those transmitting anthropometric measurement data using a mobile phone 3 or more times per week or who had a health consultation 5 or more times during a 24-week period. The passive group comprised those who did not adhere to these levels of engagement. The control group comprised those who did not use the SmartCare service. We compared changes in body weight, body mass index (BMI), body fat percentage, waist circumference, and lipid profile among the 3 groups. RESULTS We identified 422 participants and analyzed 405, excluding 17 who were missing necessary data for analysis. The active group consisted of 116 participants, compared with 80 in the passive group and 209 in the control group (without SmartCare service). There was a statistically significant difference in improvements to body weight, BMI, body fat percentage, and waist circumference among active participants compared with less active participants and the control group (P<.05). However, the lipid profile changes did not differ significantly between groups. CONCLUSIONS The level of participation may be related to improved weight-related outcomes, which may improve health outcomes. To maximize the effectiveness of the SmartCare service, encouraging active participation is important. CLINICALTRIAL Clinicaltrials.gov NCT01344811; https://clinicaltrials.gov/ct2/show/NCT01344811 (Archived by WebCite at http://www.webcitation.org/6alT2MmIB)

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.

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).

scholarly journals The Effect of Writing Therapy on Anxiety in Pregnant Women: A Randomized Controlled Trial

2020 ◽  
Vol 14 (2) ◽  
Author(s):  
Maryam Montazeri ◽  
Khalil Esmaeilpour ◽  
Sakineh Mohammad-Alizadeh-Charandabi ◽  
Sevda Golizadeh ◽  
Mojgan Mirghafourvand
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Block Design ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Writing Therapy ◽  
Randomized Block Design ◽  
Significant Difference

Background: As one of the most enjoyable life experiences, pregnancy may be accompanied by many physiological and psychological changes that make women susceptible to developing mental disorders such as anxiety. Non-pharmacological methods such as writing therapy are among the ways to deal with anxiety. Objectives: The present study aimed to determine the effect of writing therapy on anxiety in women during pregnancy. Methods: This randomized controlled trial was conducted on 70 pregnant women with a gestational age between 28 - 31 weeks. The participants were assigned to an intervention group and a control group using a randomized block design. The intervention group received three in-person writing therapy-based counseling sessions and two telephone calls between the sessions, while the control group received routine pregnancy care. The Beck anxiety inventory was completed before and six weeks after the intervention. Independent t-test and ANCOVA were used for data analysis. Results: There was no significant difference between the two groups in terms of socio-demographic variables and baseline anxiety scores. Based on ANCOVA with baseline score adjustment, the mean score of anxiety was significantly lower in the intervention group than in the control group after the intervention (adjusted mean difference = -6.8; 95%CI = -4.5 to -9.1; P < 0.001). Conclusions: According to the results, writing therapy can reduce anxiety in pregnant women; however, further studies are needed before a definitive conclusion.

scholarly journals Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Tatiana Toro-Ramos ◽  
Andreas Michaelides ◽  
Maria Anton ◽  
Zulekha Karim ◽  
Leah Kang-Oh ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Prevention Program ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Diabetes Prevention Program ◽  
Control Group ◽  
Significant Weight Loss ◽  
Randomized Controlled

BACKGROUND The Centers for Disease Control and Prevention (CDC) diabetes prevention program (DPP) has formed the foundation for Type 2 Diabetes Mellitus (T2DM) prevention efforts and lifestyle change modifications in multiple care settings. To our knowledge, no randomized controlled trial has verified the efficacy of a fully mobile version of CDC’s diabetes prevention program (DPP). OBJECTIVE This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care. METHODS Adults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP (Noom) or a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, how to interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA<sub>1c</sub> levels. RESULTS A total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In the intention-to-treat (ITT) analyses, changes in the participants’ weight and BMI were significantly different at 6 months between the intervention and control groups, but there was no difference in HbA<sub>1c</sub> levels (mean difference 0.004%, SE 0.05; <i>P</i>=.94). Weight and BMI were lower in the intervention group by −2.64 kg (SE 0.71; <i>P</i>&lt;.001) and −0.99 kg/m2 (SE 0.29; <i>P</i>=.001), respectively. These differences persisted at 12 months. However, in the analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; <i>P</i>&lt;.001) at 6 months, maintaining 4.7% (SE 0.88; <i>P</i>&lt;.001) of their weight loss at 12 months. The control group lost −0.15% at 6 months (SE 0.64; <i>P</i>=.85) and gained 0.33% (SE 0.70; <i>P</i>=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA<sub>1c</sub> level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA<sub>1c</sub> levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA<sub>1c</sub> levels. CONCLUSIONS This novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions. CLINICALTRIAL ClinicalTrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342

scholarly journals EVALUASI INTERVENSI MEDIA BOOKLET TERHADAP TINGKAT PENGETAHUAN DAN KEPATUHAN PASIEN DIABETES MELITUS TIPE 2 DI PUSKESMAS BANJARBARU SELATAN

2019 ◽  
Vol 6 (1) ◽  
Author(s):  
Valentina Meta Srikartika ◽  
M. Rasyid Akbar ◽  
Herningtyas Nautika Lingga
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
P Value ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Level Of Knowledge ◽  
Diabetes Melitus

ABSTRAKKeberhasilan pengobatan diabetes melitus tidak hanya dipengaruhi oleh kualitas pelayanan kesehatan, keterampilan petugasnya, sikap, dan pola hidup pasien, tetapi dipengaruhi juga oleh kepatuhan pasien terhadap pengobatannya. Tingkat kepatuhan minum obat pasien diabetes mellitus di Indonesia mayoritas masih berada dibawah 50%. Tujuan dari penelitian ini adalah mengukur pengaruh edukasi melalui media booklet terhadap pengetahuan dan kepatuhan pasien diabetes melitus tipe 2. Jenis penelitian yang digunakan adalah Randomized Controlled Trial (RCT). Populasi yang didapat dari penelitian ini sebanyak 40 orang dengan kelompok kontrol 20 orang dan kelompok intervensi 20 orang. Kelompok kontrol merupakan kelompok yang tidak mendapatkan booklet, sedangkan kelompok intervensi adalah kelompok yang mendapatkan booklet sebagi media edukasi. Pengetahuan dan kepatuhan responden diukur melalui kuesioner yang diberikan sebelum (pretest) dan 2 minggu kemudian (posttest). Rata-rata skor pengetahuan dan kepatuhan pre-test dibandingkan dengan skor post-test dengan menggunakan uji Wilcoxon. Berdasarkan hasil analisis, terjadi perbedaan tingkat pengetahuan dan kepatuhan yang signifikan (p value < 0,001) antara sebelum dan sesudah pemberian booklet pada kelompok intervensi dan tidak ada perbedaan yang signifikan pada tingkat pengetahuan (p value = 0,83) dan kepatuhan (p value = 0,317) pada kelompok kontrol. Oleh karena itu, dapat disimpulkan bahwa media booklet dapat meningkatkan tingkat pengetahuan dan kepatuhan pada pasien diabetes melitus.Kata-kata kunci: Diabetes melitus, pengetahuan, kepatuhan, bookletABSTRACTThe success of a treatment of diabetes mellitus is not only influenced by the quality of health services, the skills of its officers, attitudes, and lifestyle of patients, but it is also influenced by patient adherence to treatment. The level of medication compliance among diabetes patients in Indonesia were still below 50%. The purpose of this study was to measure the effect of education through booklet media on the knowledge and compliance of patients with type 2 diabetes mellitus. The type of research used was Randomized Controlled Trial (RCT). The population obtained from this study were 40 people with a control group of 20 people and an intervention group of 20 people. The control group was the group that did not get the booklet, while the intervention group was the group that received the booklet as an educational medium. Knowledge and compliance of respondents was measured through questionnaires given before (pretest) and 2 weeks later (posttest). The average score of knowledge and adherence between pretest and posttest will be compared using Wilcoxon analysis. Based on the results of data analysis with the Wilcoxon test, there was a significant difference in the level of knowledge and compliance (p value < 0.001) between before and after booklet administration in the intervention group and no significant difference in knowledge level (p value = 0.83) and compliance (p value = 0.317) in the control group. It can be concluded that the booklet media can increase the level of knowledge and compliance in diabetes mellitus patients.Keywords: Diabetes mellitus, knowledge, compliance, booklet

scholarly journals Effectiveness of WeChat for Improving Exclusive Breastfeeding in Huzhu County China: Randomized Controlled Trial

10.2196/23273 ◽  
2020 ◽  
Vol 22 (12) ◽  
pp. e23273
Author(s):  
Qiong Wu ◽  
Yiwen Huang ◽  
Zijun Liao ◽  
Michelle Helena van Velthoven ◽  
Wei Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Exclusive Breastfeeding ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mobile Technologies ◽  
Control Group ◽  
Randomized Controlled ◽  
Breastfeeding Rate ◽  
Significant Difference

Background The benefits of breastfeeding for both infants and mothers have been well recognized. However, the exclusive breastfeeding rate in China is low and decreasing. Mobile technologies have rapidly developed; communication apps such as WeChat (one of the largest social networking platforms in China) are widely used and have the potential to conveniently improve health behaviors. Objective This study aimed to assess the effectiveness of using WeChat to improve breastfeeding practices. Methods This 2-arm randomized controlled trial was conducted among pregnant women from May 2019 to April 2020 in Huzhu County, Qinghai Province, China. Pregnant women were eligible to participate if they were aged 18 years or older, were 11 to 37 weeks pregnant with a singleton fetus, had no known illness that could limit breastfeeding after childbirth, used WeChat through their smartphone, and had access to the internet. A total of 344 pregnant women were recruited at baseline, with 170 in the intervention group and 174 in the control group. Women in the intervention group received breastfeeding knowledge and promotion information weekly through a WeChat official account from their third month of pregnancy to 6 months postpartum. The primary outcome of exclusive and predominant breastfeeding rate was measured 0-1 month, 2-3 months, and 4-5 months postpartum. Results At 0-1 month postpartum, the exclusive breastfeeding rate was significantly higher in the intervention group than that in the control group (81.1% vs 63.3%; odds ratio [OR] 2.75, 95% CI 1.58-4.78; P<.001). Similarly, mothers in the intervention group were more likely to provide predominantly breast milk (OR 2.77, 95% CI 1.55-4.96; P<.001) and less likely to give dairy products to their children (OR 0.40, 95% CI 0.21-0.75; P=.005). There was no statistically significant difference for exclusive breastfeeding rate 2-3 months (P=.09) and 4-5 months postpartum (P=.27), though more children in the intervention group were exclusively breastfed than those in the control group 2-3 months postpartum (intervention: 111/152, 73.0%; control: 96/152, 63.2%) and 4-5 months postpartum(intervention: 50/108, 46.3%; control: 46/109, 42.2%). Conclusions This study is the first effort to promote exclusive breastfeeding through WeChat in China, which proved to be an effective method of promoting exclusive breastfeeding in early life. WeChat health education can be used in addition to local breastfeeding promotion programs. Trial Registration Chinese Clinical Trial Registry ChiCTR1800017364; http://www.chictr.org.cn/showproj.aspx?proj=29325 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7676-2

scholarly journals A Smartphone App to Restore Optimal Weight (SPAROW) in Women With Recent Gestational Diabetes Mellitus: Randomized Controlled Trial

10.2196/22147 ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. e22147
Author(s):  
Karen Lim ◽  
Shiao-Yng Chan ◽  
Su Lin Lim ◽  
Bee Choo Tai ◽  
Cammy Tsai ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Weight Loss ◽  
Controlled Trial ◽  
Intervention Group ◽  
Caloric Intake ◽  
First Trimester ◽  
Control Group ◽  
Optimal Weight ◽  
Randomized Controlled

Background Women with a history of gestational diabetes mellitus (GDM) are at an increased risk of developing type 2 diabetes mellitus (T2DM). Lifestyle interventions aimed at postpartum weight loss to reduce T2DM risk have been reported, but poor compliance remains a barrier. Smartphone-based interventions may improve compliance, but data on its use in women with recent GDM are limited. Objective This trial aimed to investigate the efficacy of a smartphone app in restoring optimal weight following delivery in women with GDM, in the setting of a population with high rates of GDM and type 2 diabetes. Methods In this unblinded randomized controlled trial, 200 women with GDM were randomized to receive the intervention or standard care following delivery. The intervention enabled logging of weight, meals, and activity, with web-based interaction with a team comprising dieticians, a physiotherapist, and an occupational therapist. The primary outcome was an achievement of optimal weight (defined as the restoration of first trimester weight if first trimester BMI≤23 kg/m2 or weight loss of at least 5% from first trimester weight if first trimester BMI>23 kg/m2) at 4 months post partum. Secondary outcome measures included absolute weight loss, serum metabolic markers, self-reported nutritional intake, health education, and quality of life via questionnaires and user engagement in the intervention group. Results In total, 40% (38/96) of women in the intervention group achieved optimal weight at 4 months post delivery compared with 32% (28/93) in the control group (P=.27). Compared with the control group, women in the intervention group reported significantly reduced caloric intake at 4 months after delivery (P<.001) and higher health-directed behavior scores (P=.045). The intervention group also reported increased emotional distress scores (P=.01). At 4 months, participant engagement with the intervention was maintained at 60.8% (SD 33.9%). Conclusions Although a statistically significant increase in women achieving healthy weight was not observed, this app remains promising, as women in the intervention group reported improved health behaviors and lower caloric intake. Importantly, the high retention rates suggest that a larger study with a longer follow-up period might confirm the effectiveness of this app for weight management. Trial Registration ClinicalTrials.gov NCT03324737; https://clinicaltrials.gov/ct2/show/NCT03324737 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7691-3

scholarly journals Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial

10.2196/17842 ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. e17842
Author(s):  
Tatiana Toro-Ramos ◽  
Andreas Michaelides ◽  
Maria Anton ◽  
Zulekha Karim ◽  
Leah Kang-Oh ◽  
...  
Keyword(s):  
Weight Loss ◽  
Prevention Program ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Diabetes Prevention Program ◽  
Control Group ◽  
Significant Weight Loss ◽  
Randomized Controlled ◽  
Hba1c Levels

Background The Centers for Disease Control and Prevention (CDC) diabetes prevention program (DPP) has formed the foundation for Type 2 Diabetes Mellitus (T2DM) prevention efforts and lifestyle change modifications in multiple care settings. To our knowledge, no randomized controlled trial has verified the efficacy of a fully mobile version of CDC’s diabetes prevention program (DPP). Objective This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care. Methods Adults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP (Noom) or a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, how to interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A1c (HbA1c) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA1c levels. Results A total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In the intention-to-treat (ITT) analyses, changes in the participants’ weight and BMI were significantly different at 6 months between the intervention and control groups, but there was no difference in HbA1c levels (mean difference 0.004%, SE 0.05; P=.94). Weight and BMI were lower in the intervention group by −2.64 kg (SE 0.71; P<.001) and −0.99 kg/m2 (SE 0.29; P=.001), respectively. These differences persisted at 12 months. However, in the analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; P<.001) at 6 months, maintaining 4.7% (SE 0.88; P<.001) of their weight loss at 12 months. The control group lost −0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA1c level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA1c levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA1c levels. Conclusions This novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions. Trial Registration ClinicalTrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342

scholarly journals Methylprednisolone or Dexamethasone, Which One Is the Superior Corticosteroid in the Treatment of Hospitalized COVID-19 Patients: A Triple-Blinded Randomized Controlled Trial

2021 ◽  
Author(s):  
Keivan Ranjbar ◽  
Reza Shahriarirad ◽  
Amirhossein Erfani ◽  
Zohre Khodamoradi ◽  
Mohammad Hasan Gholampoor Saadi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Status ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Ordinal Scale ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
And Control

Abstract BackgroundAlthough 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, unsolved issues remained to choose appropriate corticosteroids treatment for COVID-19. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients.MethodIn this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. Patients were randomly allocated into two groups to receive either methylprednisolone (2mg/kg/day) or dexamethasone (6mg/kg/day). Data was assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8).ResultsThere was no significant variation among the groups on the 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).ConclusionIn the context of treating 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).

No evidence of effectiveness of mirror therapy early after stroke: an assessor-blinded randomized controlled trial

2019 ◽  
Vol 33 (5) ◽  
pp. 885-893 ◽  
Author(s):  
Paola Antoniotti ◽  
Laura Veronelli ◽  
Antonio Caronni ◽  
Alessia Monti ◽  
Evdoxia Aristidou ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Upper Limb ◽  
Controlled Trial ◽  
Intervention Group ◽  
Functional Independence ◽  
Control Group ◽  
Mirror Therapy ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Flexion Extension

Objective: The aim of this study was to investigate the efficacy of mirror therapy on upper-limb recovery in early post-stroke patients. Design: Assessor-blinded randomized controlled trial. Setting: Inpatient rehabilitation clinic. Subjects: A total of 40 patients with upper-limb impairment due to a first-ever ischaemic or haemorrhagic stroke, within four weeks from the cerebrovascular accident. Intervention: The intervention group received mirror therapy, while the control group received sham therapy. During mirror therapy, patients’ sound hand was reflected by a mirror. During sham therapy, an opaque surface replaced the mirror-reflecting surface. Both the mirror therapy and sham therapy groups practised their sound hand with exercises, ranging from the simple elbow flexion–extension to complex tasks (e.g. reaching and grasping). Mirror therapy and sham therapy were added to conventional rehabilitation. Main measures: Primary outcome includes Fugl–Meyer upper extremity scale. Secondary outcomes include action research arm test (ARAT) and functional independence measure (FIM) scale. Outcomes were measured at the beginning (T0) and end (T1) of the treatment. Results: At baseline, both groups (sham therapy vs. mirror therapy; mean (SD)) were comparable for Fugl–Meyer (30.9 (23.9) vs. 28.5 (21.8)), ARAT (25.1 (25.5) vs. 23.5 (24)) and FIM (71.0 (20.6) vs. 72.9 (17.8)) scores. At the end of the treatment, both groups significantly improved in the Fugl–Meyer (40.6 (21.3) vs. 38.3 (23.4)), ARAT (31.9 (23.0) vs. 30 (24.1)) and FIM (100.3 (21.9) vs. 99.4 (22.6)) scores. However, at T1, no significant difference was observed between the sham therapy and mirror therapy groups, neither for the Fugl–Meyer, nor for ARAT and FIM scores. Conclusion: Compared with sham therapy, mirror therapy did not add additional benefit to upper-limb recovery early after stroke.

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