Effect of ICT-Based Self-Management System DialBeticsLite on Treating Abdominal Obesity: Randomized Controlled Trial. (Preprint)

2021 ◽  
Author(s):  
Masahiro Kondo ◽  
Teru Okitsu ◽  
Kayo Waki ◽  
Toshimasa Yamauchi ◽  
Masaomi Nangaku ◽  
...  
Keyword(s):  
Abdominal Obesity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Metabolic Parameters ◽  
Control Group ◽  
Physical Parameters ◽  
Lifestyle Behavior ◽  
Randomized Controlled

BACKGROUND Mobile health interventions, a more cost-effective approach compared to traditional methods of delivering lifestyle coaching in person, have been shown to improve physical parameters and lifestyle behavior among overweight populations. It is useful to know the efficacy of mobile apps in treating abdominal obesity, as it is a known risk factor for metabolic disorders and type 2 diabetes. OBJECTIVE This study aimed to determine whether a mobile self-management app (DialBeticsLite) could be used by patients with abdominal obesity to achieve a reduction in visceral fat area (VFA) and other physical parameters. METHODS This study was an open-label, 2-arm parallel-design randomized controlled trial. We recruited 122 people in September 2017, and randomly assigned them into either the intervention group or the control group. All participants attended an educational group session, which delivered information regarding diet and exercise. Additionally, participants in the intervention group were asked to use DialBeticsLite for 3 months. DialBeticsLite facilitated the daily recording of several physical parameters and lifestyle behavior, and provided feedback to encourage an improvement in behavior. The primary outcome was the change in VFA from baseline to the 3-month follow-up. Secondary outcomes included changes in both physical and metabolic parameters, from baseline to the 3-month follow-up. Welch t test was conducted to analyze the effects of DialBeticsLite on both the primary outcome and the secondary outcomes. RESULTS Out of the 122 participants recruited, 75 participants were analyzed due to 47 participants being excluded: 37 due to ineligibility and 10 due to withdrawal of consent. The mean age was 49.3 (standard deviation: SD 6.1) in the intervention group (n=41) and 48.5 (SD 5.3) in the control group (n=34), and all participants were male, though unintentionally. Baseline characteristics did not differ significantly between the intervention and control group, except for VFA. The averaged change of VFA was -23.5cm2 (SD 20.6) in the intervention group and +1.9cm2 (SD 16.2) in the control group (P<.001). Statistically significant differences were also found for the change of body weight, BMI and waist circumference. These findings did not change after adjusting for VFA at baseline. The intervention had no significant effect on any of the metabolic parameters. An exploratory analysis showed significant associations between the change in VFA and steps per day, and between the change in VFA and calorie intake per day within the intervention group. CONCLUSIONS Our findings indicate that although unsuccessful in improving metabolic parameters, a mobile health intervention facilitating the daily monitoring of several physical parameters and lifestyle behavior, can be highly effective in inducing visceral fat loss and weight loss among adults with abdominal obesity. CLINICALTRIAL Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000042045 Retrospectively Registered; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000046495&type=summary&llanguag=J

scholarly journals Mobilization in the evening reduces delirium in critically ill patients: the MENTAL randomized, controlled trial

2019 ◽  
Author(s):  
Peter Nydahl ◽  
David McWilliams ◽  
Norbert Weiler ◽  
Christoph Borzikowsky ◽  
Fiona Howroyd ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Early Mobilization ◽  
Control Group ◽  
Number Needed To Treat ◽  
Randomized Controlled ◽  
Post Hoc

Abstract Background : Delirium is a common complication in patients on Intensive Care Units (ICU). Caring interventions such as early mobilization are effective in prevention and treatment of delirium, but are recommended during daytime. It may be effective in the night, too. Method : The aim of this study was to prove the effect of mobilization in the evening to prevent or treat ICU patients from delirium. The design was a multicentric, randomized, controlled trial in 5 mixed ICUs over a period of 2 weeks with max. 28 days follow-up. Patients in the intervention group were mobilized onto the edge of the bed or more between 9:00 and 11:00 p.m. by an additional mobilization team, following safety criteria. Patients in the control group received usual care. Primary outcome parameter was the duration of a delirium. Secondary parameters were presence of delirium, mortality, duration of mechanical ventilation (MV) and stay, feasibility, and mobilization-related complications. Results : In summary, n=69 patients could be analysed (intervention n=36, control n=33). Due to limited resources, the trial was stopped and reached 62% of targeted sample size. Mobilization in the evening did not significantly reduce duration of existing delirium, delirium presence, length of MV or days in ICU and hospital for 28 days follow-up. In an unplanned post-hoc analysis, mobilization in the evening prevented patients from delirium in the first four days (6 (16.7%) vs. 13 (39.4%), p=0.032), with a number needed to treat of 5. The intervention was feasible in 71.7% of eligible patients, with 13.6% unwanted safety events. Conclusions : In a mixed ICU population, mobilization in the evening did not show a reduction in duration of delirium, MV or length of stay, but a reduction in the incidence of early onset delirium. Mobilization between 9:00 and 11:00 pm. by an interprofessional mobilization team may prevent patients from delirium. The intervention was feasible, safe, and accepted by most patients.

scholarly journals Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

2021 ◽  
Vol 27 (1) ◽  
pp. 146045822199640
Author(s):  
Faranak Kazemi Majd ◽  
Vahideh Zarea Gavgani ◽  
Ali Golmohammadi ◽  
Ali Jafari-Khounigh
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Readmission ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

scholarly journals Effects of individualized follow-up with a smartphone-application after cardiac rehabilitation: protocol of a randomized controlled trial

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Pernille Lunde ◽  
Asta Bye ◽  
Astrid Bergland ◽  
Birgitta Blakstad Nilsson
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Smartphone Application ◽  
Control Group ◽  
Power Calculation ◽  
Large Sample Size ◽  
Randomized Controlled

Abstract Background Cardiac rehabilitation (CR) programs are evidence-based and widely recommended. However, benefits from CR are likely lost among individuals who discontinue their regular exercise routines and healthy habits. One possible approach to enhance adherence to lifestyle advice after completion of CR, may be individualized follow-up enabled by a smartphone application (app). Methods A protocol of a single-blinded, pragmatic randomized controlled trial. The study will take place in the eastern part of Norway, and will include heart patients who have completed CR. Participants will be recruited from two CR centers. Based on power calculation, 113 participants will be included. The intervention group will receive individualized follow-up through an app on a weekly basis throughout a year. The app will be set up with the participant’s own goals, and the follow-up will be based on these individual goals. The control group will receive usual care, including general advice regarding physical activity, exercise and diet. The participants will be assessed at baseline (at completion of CR) and 12 months after baseline. Primary outcome of the study will be peak oxygen uptake. Secondary outcomes include exercise performance, quality of life, health status, health literacy, self-perceived goal achievement, exercise habits, body weight, blood pressure as well as lipids and triglycerides. Discussion To our knowledge, this will be the first study to examine the effects of individualized follow-up with an app for one year, in patients completing CR. Hence, it is reasonable to assume that the study may be groundbreaking. Due to the large sample size and the theoretically based intervention, the study has the potential to generate new knowledge that may improve the design of future technology-based follow-up interventions of patients that have completed rehabilitation. Trial registration ClinicalTrials.gov. NCT03174106. First registration, 19/05/2017.

Long-term efficacy of indicated prevention of depression in non-professional caregivers: randomized controlled trial

2014 ◽  
Vol 45 (7) ◽  
pp. 1401-1412 ◽  
Author(s):  
P. Otero ◽  
F. Smit ◽  
P. Cuijpers ◽  
A. Torres ◽  
V. Blanco ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Caregiver Burden ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Indicated Prevention ◽  
Randomized Controlled ◽  
Term Efficacy

BackgroundAlthough depression is a common problem among non-professional caregivers, only one trial has evaluated the efficacy of indicated prevention targeting this population and the long-term efficacy is unknown. The aim of this study was to evaluate the long-term efficacy of a brief intervention for the indicated prevention of depression in a sample of female caregivers.MethodA randomized controlled trial was conducted involving 173 participants (mean age 53.9 years) who were allocated to the intervention (n = 89) or the usual-care control group (n = 84). Blinded interviewers conducted assessments at 1, 3, 6 and 12 months of follow-up. The main outcome measure was the incidence of major depression and the secondary outcomes were compliance with treatment, depressive symptoms, emotional distress and caregiver burden.ResultsAt the 12-month follow-up, a lower incidence of depression as evaluated using the Structured Clinical Interview for Axis I Disorders of the DSM-IV was found in the intervention group compared with the control group (10.1%v.25.0%). The relative risk was 0.40 and statistically significant [χ2 = 6.68, degrees of freedom = 1,p = 0.010, 95% confidence interval (CI) 0.20–0.81], and the number needed to treat was 7 (95% CI 4–27). There was a significant delay in the onset of depression in the intervention group (p = 0.008). The good complier caregivers had a lower incidence of depression. The intervention effect on depressive symptoms, emotional distress and caregiver burden were maintained for 12 months.ConclusionsThis is the first study to demonstrate that a brief problem-solving intervention can prevent the onset of depression among non-professional caregivers over the longer term.

Enhanced early sensory outcome after nerve repair as a result of immediate post-operative re-learning: a randomized controlled trial

2014 ◽  
Vol 40 (6) ◽  
pp. 598-606 ◽  
Author(s):  
B. Rosén ◽  
P. Vikström ◽  
S. Turner ◽  
D. A. McGrouther ◽  
R. W. Selles ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Nerve Repair ◽  
Intervention Group ◽  
Control Group ◽  
Level Of Evidence ◽  
Test Part ◽  
Randomized Controlled ◽  
Identification Test

We assessed the use of guided plasticity training to improve the outcome in the first 6 months after nerve repair. In a multicentre randomized controlled trial, 37 adults with median or ulnar nerve repair at the distal forearm were randomized to intervention, starting the first week after surgery with sensory and motor re-learning using mirror visual feedback and observation of touch, or to a control group with re-learning starting when reinnervation could be detected. The primary outcome at 3 and 6 months post-operatively was discriminative touch (shape texture identification test, part of the Rosen score). At 6 months, discriminative touch was significantly better in the early intervention group. Improvement of discriminative touch between 3 and 6 months was also significantly greater in that group. There were no significant differences in motor function, pain or in the total score. We conclude that early re-learning using guided plasticity may have a potential to improve the outcomes after nerve repair. Level of evidence: II

scholarly journals A Brief Body-Mind-Spirit Group Therapy for Chinese Medicine Stagnation Syndrome: A Randomized Controlled Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Siu-man Ng ◽  
Lingli Leng ◽  
Rainbow T. H. Ho ◽  
Zhangjin Zhang ◽  
Qi Wang
Keyword(s):  
Group Therapy ◽  
Effect Size ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Eta Squared ◽  
Physical Distress

Background. Stagnation syndrome, a diagnostic entity in traditional Chinese medicine (TCM), is characterized by mind-body obstruction-like symptoms. Although TCM has long-established symptom-relief treatments, a comprehensive mind-body intervention was called for. Purpose. The study evaluated the efficacy of a six-session body-mind-spirit (BMS) group therapy for persons with stagnation syndrome. Method. A 2-arm randomized controlled trial design was adopted. The control group received a parallel general TCM instruction course. Both groups completed a pretest (T0), posttest (T1), and 2-month follow-up assessment (T2). The measures included self-report scales on stagnation, depression, anxiety, physical distress, daily functioning, and positive and negative affect; the other measure was of salivary cortisol, a biological marker of stress. Results. Data on 111 adults with stagnation syndrome were included in the analysis. Completion rates were high (over 87%) for both the intervention and control groups. Repeated-measures multivariate MANOVA revealed a significant combined effect with large effect size (eta-squared = 0.42). Repeated-measures ANOVA further revealed that the intervention group showed significant improvements in stagnation, the primary outcome, with medium effect size (eta-squared = 0.11). The intervention group also showed significant improvements in depression, physical distress, everyday functioning, and negative affect (eta-squared = 0.06 to 0.13). Post hoc analysis revealed that the intervention group showed significant improvements over the control group in cortisol level at 2-month follow-up assessment (T0 versus T2) with small effect size (eta-squared = 0.05), but not at posttest (T0 versus T1). Conclusions. Overall, the findings indicate that our brief BMS group therapy intervention for stagnation syndrome is efficacious. Moreover, the intervention resulted in a number of substantial improvements in the physical and mental health domains.

Randomized Controlled Trial Evaluating Pictogram Augmentation of HIV Medication Information

2011 ◽  
Vol 45 (11) ◽  
pp. 1378-1383 ◽  
Author(s):  
Kyle Wilby ◽  
Carlo A Marra ◽  
Jack H da Silva ◽  
Maja Grubisic ◽  
Stephanie Harvard ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antiretroviral Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Fisher Exact Test ◽  
Intended Meaning ◽  
Randomized Controlled ◽  
Medication Information

Background:: Antiretroviral therapy for the management of HIV typically requires the chronic use of 3 or more medications. As such, patients with HIV are required to manage complex dosing schedules and are at risk of multiple potential adverse effects. The use of pictograms on medication vials as a means of improving patients' understanding of medication information has been shown to positively influence understanding and adherence compared to those using text atone. Objective: To determine whether pictograms (Pharmaglyph) increase patient recall of targeted information associated with HIV medications and whether patients can interpret the intended meaning of pictograms that they had not seen previously. Methods: A randomized, controlled trial was conducted in HIV-positive patients aged 19 years or older who were receiving a new prescription for an antiretroviral medication from the ambulatory pharmacy at St. Paul's Hospital in Vancouver, British Columbia, Canada. Participants were randomized to receive either pictogram-enhanced medication information or standard counseling. At the first follow-up visit, each patient's recall of the medication information was evaluated, and differences between groups were compared. Results: Eighty-two subjects were randomized, 40 to the intervention group and 42 to the control arm. The mean (SD) number of HIV medications was nearly equal between the intervention and control groups: 3.0 (1.5) and 3.1 (1.4), respectively. After a mean of 34 days, 33 patients in the intervention arm and 39 in the control arm completed the study. The majority (88%) of the targeted pieces of information in the intervention group were correctly identified at follow-up, compared to only 2% in the control group (Fisher exact test; p < 0.0001). Conclusions: Pictograms improve the recall of targeted medication information among patients receiving antiretroviral therapy for HIV management; however, this appears to be dependent on the fact that these patients received a verbal explanation of each pictogram prior to use.

scholarly journals Effectiveness of a Worksite Intervention for Male Construction Workers on Dietary and Physical Activity Behaviors, Body Mass Index, and Health Outcomes: Results of a Randomized Controlled Trial

2017 ◽  
Vol 32 (3) ◽  
pp. 795-805 ◽  
Author(s):  
Laura Viester ◽  
Evert A. L. M. Verhagen ◽  
Paulien M. Bongers ◽  
Allard J. van der Beek
Keyword(s):  
Physical Activity ◽  
Controlled Trial ◽  
Intervention Group ◽  
Construction Workers ◽  
Blue Collar ◽  
Control Group ◽  
Intervention Effect ◽  
Lifestyle Behavior ◽  
Randomized Controlled ◽  
Sweetened Beverages

Purpose: To evaluate the effectiveness of an individually tailored intervention for improvement in lifestyle behavior, health indicators, and prevention and reduction of overweight among construction workers. Design: Randomized controlled trial. Setting: Various blue-collar departments of a large construction company in the Netherlands. Participants: Blue-collar workers randomized to an intervention (n = 162) or a control group (n = 152). Intervention: The intervention group received individual coaching sessions, tailored information, and materials to improve lifestyle behavior during a 6-month period, and the control group received usual care. Measures: Body weight, body mass index (BMI), waist circumference, physical activity (PA) levels, dietary behavior, blood pressure, and blood cholesterol were assessed. Analysis: Effectiveness of the intervention on outcome measures at 6- and 12-month follow-up was assessed by using linear and logistic regression models adjusting for baseline levels. Results: After 6 months, a statistically significant intervention effect was found on body weight ( B = −1.06, P = .010), BMI ( B = −0.32, P = .010), and waist circumference ( B = −1.38, P = .032). At 6 months, the percentage of those meeting public health guidelines for PA increased significantly in the intervention group compared to the control group ( B = 2.06, P = .032), and for sugar-sweetened beverages, an intervention effect was found at 6 months as well ( B = −2.82, P = .003). At 12 months, for weight-related outcomes, these differences were slightly smaller and no longer statistically significant. The intervention was not effective on the total amount of moderate to vigorous PA and other dietary and health outcomes. Conclusion: Intervention participants showed positive changes in vigorous PA and intake of sugar-sweetened beverages compared to controls, as well as effects on weight-related outcomes at 6 months. Long-term effects were still promising but not statistically significant.

scholarly journals Effectiveness of a smartphone-based, augmented reality exposure app to reduce fear of spiders in real-life: a randomized controlled trial

2021 ◽  
Author(s):  
Anja Zimmer ◽  
Nan Wang ◽  
Merle Ibach ◽  
Bernhard Fehlmann ◽  
Nathalie Schicktanz ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Augmented Reality ◽  
Controlled Trial ◽  
Intervention Group ◽  
Real Life ◽  
Control Group ◽  
Randomized Controlled ◽  
Distress Scale

Although in vivo exposure therapy is highly effective in the treatment of specific phobias, only a minority of patients seeks therapy. Exposure to virtual objects has been shown to be better tolerated, equally efficacious, but the technology has not been made widely accessible yet. We developed an augmented reality (AR) application (app) to reduce fear of spiders and performed a randomized controlled trial comparing the effects of our app (six 30-min sessions at home over a two-week period) with no intervention. Primary outcome was subjective fear, measured by a Subjective Units of Distress Scale (SUDS) in a Behavioural Approach Test (BAT) in a real-life spider situation at six weeks follow-up. Between Oct 7, 2019, and Dec 6, 2019, 66 individuals were enrolled and randomized. The intervention led to significantly lower subjective fear in the BAT compared to the control group (intervention group, baseline: 7·12 [SD 2·03] follow-up: 5·03 [SD 2·19] vs. control group, baseline: 7·06 [SD 2·34], follow-up 6·24 [SD 2.21]; adjusted group difference -1·24, 95% CI -2·17 to -0·31; Cohen’s d=0·57, p=0·01). The repeated use of the AR app reduces subjective fear in a real-life spider situation, providing a low-threshold and low-cost treatment for fear of spiders.

scholarly journals Influence of a Survival Swimming Training Programme on Water Safety Knowledge, Attitudes and Skills: A Randomized Controlled Trial among Young Adults in Sri Lanka

2021 ◽  
Vol 18 (21) ◽  
pp. 11428
Author(s):  
Jeewanthika Ekanayaka ◽  
Chan Kim Geok ◽  
Bernadette Matthews ◽  
Samath D. Dharmaratne
Keyword(s):  
Randomized Controlled Trial ◽  
Young Adults ◽  
Sri Lanka ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Water Safety ◽  
Randomized Controlled ◽  
Safety Knowledge

Drowning among young adults is high in Sri Lanka. Water safety education is a recommended strategy for drowning prevention but is often overlooked for young adults. This study aimed to evaluate the effectiveness of an adapted educational intervention, “Swim for Safety” on improving water safety knowledge, attitudes and survival swimming skills among undergraduates (19–28 years) in Sri Lanka. This study employed a parallel-group, two-arm randomized controlled trial design. The intervention group (n = 78) received a face-to-face, 12-lesson education programme, and the control group (n = 78) received a brochure and weekly mobile phone messages for six consecutive weeks. Baseline, post-intervention and three-month follow-up knowledge, attitudes and skills were evaluated. Knowledge and attitudes were assessed using a self-administered questionnaire and skills were evaluated following a skills assessment protocol. In total 116 participants, 60 intervention group and 56 control group, completed the study. At baseline there were no differences between groups in median scores of water safety knowledge, attitudes and survival swimming skills. The intervention group demonstrated statistically significant increases in median water safety knowledge, attitudes and survival swimming skill scores compared with the control group, following the intervention and maintained at three-month follow-up (p < 0.05). The adapted Swim for Safety programme significantly improved water safety knowledge, attitudes, and survival swimming skills among young adults in Sri Lanka. Therefore, it is recommended that the SfS programme be implemented widely to prevent drowning in young adults.

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