scholarly journals A Randomized Controlled Trial to Reduce Lifestyle Related Risk Factors for Non-Communicable Diseases through Funeral Societies in Sri Lanka

2017 ◽  
Vol 12 (31) ◽  
pp. 2194-2212
Author(s):  
Thushani Marie Elizabeth Dabrera ◽  
Arunasalem Pathmeswaran ◽  
Anuradhani Kasturirathna ◽  
Gayani Tillekeratne ◽  
Truls Østbye
Keyword(s):  
Randomized Controlled Trial ◽  
Sri Lanka ◽  
Fruits And Vegetables ◽  
Controlled Trial ◽  
Communicable Diseases ◽  
Control Group ◽  
Control Groups ◽  
Non Communicable Diseases ◽  
Randomized Controlled ◽  
Western Province

A cluster randomized controlled trial was conducted to change diet, physical activity, smoking and alcohol consumption among participants through funeral societies in the Western Province. Twenty one administrative subdivisions in the Ragama area were randomized into intervention and control groups. Ten administrative subdivisions in the North Western Province were selected as an additional control group. The primary outcome was change in the proportion of individuals who consumed 5 servings or more of fruits and vegetables per day. The study showed only a modest, not significant increase in the proportion of people consuming 5 servings of fruits and vegetables or more per day. Of the secondary outcomes assessed, their intake of green leaves and mean MET minutes spent on leisure activities increased significantly more in the intervention group than in the control groups, but the differences were small. To effectively reduce non-communicable diseases (NCD) in Sri Lanka, community-based organizations could be utilized to deliver prevention programs.

scholarly journals Effects of Phase IV Pedometer Feedback Home-Based Cardiac Rehabilitation on Cardiovascular Functional Capacity in Patients With Myocardial Infarction: A Randomized Controlled Trial

2019 ◽  
Vol 4 (2) ◽  
pp. 75-80
Author(s):  
Mostafa Dehghani ◽  
Mostafa Cheraghi ◽  
Mehrdad Namdari ◽  
Valiollah Dabidi Roshan
Keyword(s):  
Myocardial Infarction ◽  
Randomized Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Functional Capacity ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
Randomized Controlled ◽  
Home Based

Introduction: Pedometer feedback home-based cardiac rehabilitation (PFHCR) programs have been effective in augmenting exercise tolerance. Our aim was to investigate the effects of PFHCR on cardiovascular functional capacity in patients with myocardial infarction (MI).Methods: Forty MI patients were divided into two intervention and two control groups (n=10)in a randomized controlled trial. The intervention group received a PFHCR program including routine medications along with continuous exercise program, whereas the control group received traditional care without PFHCR. Baseline evaluations and cardiovascular stresses were controlled during the 8-week follow-up rehabilitation program in all patients. Data analysis was conducted using one-way ANOVA and paired sample student’s t-test (P ≤ 0.05).Results: At baseline, no significant differences were observed between the groups. After eight weeks of PFHCR, the intervention groups had significantly higher metabolic equivalent(P = 0.001), VO2max (P = 0.001), total exercise times (P = 0.001), and total distance traveled(P = 0.003) when compared with the control groups. However, no significant intra-group or inter-group differences in variables were observed between the men and women.Conclusion: Our results showed that PFHCR exhibited significant optimal effects on the cardiovascular functional capacity in MI patients.

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.

scholarly journals Exercise and Horticultural Programs for Older Adults with Depressive Symptoms and Memory Problems: A Randomized Controlled Trial

2019 ◽  
Vol 9 (1) ◽  
pp. 99 ◽  
Author(s):  
Hyuma Makizako ◽  
Kota Tsutsumimoto ◽  
Takehiko Doi ◽  
Keitaro Makino ◽  
Sho Nakakubo ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Exercise Group ◽  
Control Group ◽  
Control Groups ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Memory Problems

Depressive symptoms and memory problems are risk factors for dementia. Exercise can reduce these in older people, and horticultural activity can benefit people with dementia. This study assessed the efficacy of exercise and horticultural interventions for community-dwelling older adults with depressive symptoms and mild memory decline. In this randomized controlled trial, older adults (n = 89) were assigned to exercise, horticultural, or control groups. Exercise and horticultural programs included 20 weekly 90-min sessions. The control group attended two 90-min classes. Outcomes were assessed at baseline, and then 6- and 12-months post-intervention. Primary outcome measures were the Geriatric Depression Scale-15 (GDS-15) and Wechsler Memory Scale-Revised. Walking speed, two-minute walking test scores, social network, life space, and subjective daily physical activity were secondary outcome measures. Compared with the control group, the exercise group obtained higher immediate and delayed recall logical memory scores, and the increase in immediate recall scores remained 12-months post-intervention. Two-minute walking performance improved in the exercise group, but not after 12 months. GDS-15 scores showed no significant improvements. The horticultural and control groups showed no differences. Exercise may improve memory, while horticultural activity may not. The effects of exercise and horticultural interventions on depressive symptoms remain unclear.

scholarly journals Protocol violations in López-Medina et al.: 38 switched ivermectin (IVM) and placebo doses, failure of blinding, widespread IVM sales OTC in Cali, and nearly identical AEs for the IVM and control groups

2021 ◽  
Author(s):  
David Scheim ◽  
Jennifer A. Hibberd ◽  
Juan Chamie-Quintero
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Controlled Trial ◽  
Control Group ◽  
High Dose ◽  
Control Groups ◽  
Over The Counter ◽  
Randomized Controlled ◽  
Widespread Availability ◽  
And Control

A randomized controlled trial for treatment of mild cases of COVID-19 conducted in Cali, Colombia reported no statistically significant differences in outcomes for its ivermectin (IVM) and placebo arms. A striking anomaly, however, was that certain adverse events (AEs) that are distinctive for the study’s high-dose IVM use occurred at nearly identical rates in its IVM and placebo arms. The backdrop for these indicators of IVM use in study controls was widespread sales of IVM for COVID-19 in the Cali area during the study period, with 1.6 IVM doses sold over the counter for each case of COVID-19. The study compounded these risks of contamination of the control arm with critical errors in blinding and segregation of IVM v. placebo doses. A labeling error substituted IVM for placebo doses of 38 patients. Also, 5% dextrose solution was used for several weeks as a placebo, easily distinguishable from bitter tasting IVM. Given widespread availability and sales of IVM in Cali, lapses in segregation and blinding of IVM and control doses, and IVM-characteristic AEs in controls, the integrity of the study’s control arm was violated. Some useful information can nevertheless be salvaged from outcomes of this study’s IVM treatment arm, which had 0 deaths and generally mild symptoms, with AEs typical for high-dose IVM (replicated in the control group) that were generally mild and transient.

scholarly journals Did awarding badges increase data sharing in BMJ Open ? A randomized controlled trial

2020 ◽  
Vol 7 (3) ◽  
pp. 191818 ◽  
Author(s):  
Anisa Rowhani-Farid ◽  
Adrian Aldcroft ◽  
Adrian G. Barnett
Keyword(s):  
Randomized Controlled Trial ◽  
Data Sharing ◽  
Controlled Trial ◽  
Intervention Group ◽  
Open Data ◽  
Research Articles ◽  
Control Group ◽  
Control Groups ◽  
Randomized Controlled ◽  
And Control

Sharing data and code are important components of reproducible research. Data sharing in research is widely discussed in the literature; however, there are no well-established evidence-based incentives that reward data sharing, nor randomized studies that demonstrate the effectiveness of data sharing policies at increasing data sharing. A simple incentive, such as an Open Data Badge, might provide the change needed to increase data sharing in health and medical research. This study was a parallel group randomized controlled trial (protocol registration: doi:10.17605/OSF.IO/PXWZQ ) with two groups, control and intervention, with 80 research articles published in BMJ Open per group, with a total of 160 research articles. The intervention group received an email offer for an Open Data Badge if they shared their data along with their final publication and the control group received an email with no offer of a badge if they shared their data with their final publication. The primary outcome was the data sharing rate. Badges did not noticeably motivate researchers who published in BMJ Open to share their data; the odds of awarding badges were nearly equal in the intervention and control groups (odds ratio = 0.9, 95% CI [0.1, 9.0]). Data sharing rates were low in both groups, with just two datasets shared in each of the intervention and control groups. The global movement towards open science has made significant gains with the development of numerous data sharing policies and tools. What remains to be established is an effective incentive that motivates researchers to take up such tools to share their data.

scholarly journals Gait Retraining for the Reduction of Injury Occurrence in Novice Distance Runners: 1-Year Follow-up of a Randomized Controlled Trial

2017 ◽  
Vol 46 (2) ◽  
pp. 388-395 ◽  
Author(s):  
Zoe Y.S. Chan ◽  
Janet H. Zhang ◽  
Ivan P.H. Au ◽  
Winko W. An ◽  
Gary L.K. Shum ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Control Groups ◽  
Gait Retraining ◽  
Loading Rates ◽  
Vertical Loading ◽  
Randomized Controlled ◽  
And Control

Background: The increasing popularity of distance running has been accompanied by an increase in running-related injuries, such that up to 85% of novice runners incur an injury in a given year. Previous studies have used a gait retraining program to successfully lower impact loading, which has been associated with many running ailments. However, softer footfalls may not necessarily prevent running injury. Purpose: To examine vertical loading rates before and after a gait retraining program and assess the effectiveness of the program in reducing the occurrence of running-related injury across a 12-month observation period. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 320 novice runners from the local running club completed this study. All the participants underwent a baseline running biomechanics evaluation on an instrumented treadmill with their usual running shoes at 8 and 12 km/h. Participants were then randomly assigned to either the gait retraining group or the control group. In the gait retraining group (n = 166), participants received 2 weeks of gait retraining with real-time visual feedback. In the control group (n = 154), participants received treadmill running exercise but without visual feedback on their performance. The training time was identical between the 2 groups. Participants’ running mechanics were reassessed after the training, and their 12-month posttraining injury profiles were tracked by use of an online surveillance platform. Results: A significant reduction was found in the vertical loading rates at both testing speeds in the gait retraining group ( P < .001, Cohen’s d > 0.99), whereas the loading rates were either similar or slightly increased in the control group after training ( P = .001 to 0.461, Cohen’s d = 0.03 to −0.14). At 12-month follow-up, the occurrence of running-related musculoskeletal injury was 16% and 38% in the gait retraining and control groups, respectively. The hazard ratio between gait retraining and control groups was 0.38 (95% CI, 0.25-0.59), indicating a 62% lower injury risk in gait-retrained runners compared with controls. Conclusion: A 2-week gait retraining program is effective in lowering impact loading in novice runners. More important, the occurrence of injury is 62% lower after 2 weeks of running gait modification. Registration: HKUCTR-1996 (University of Hong Kong Clinical Trials Registry).

scholarly journals SToRytelling to Improve Disease outcomes in Gout (STRIDE-GO): a multicenter, randomized controlled trial in African American veterans with gout

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Jasvinder A. Singh ◽  
Amy Joseph ◽  
Joshua Baker ◽  
Joshua S. Richman ◽  
Terrence Shaneyfelt ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stress Reduction ◽  
Controlled Trial ◽  
Attention Control ◽  
Control Group ◽  
Culturally Appropriate ◽  
Control Groups ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Gout Flares

Abstract Background Urate-lowering therapy (ULT) adherence is low in gout, and few, if any, effective, low-cost, interventions are available. Our objective was to assess if a culturally appropriate gout-storytelling intervention is superior to an attention control for improving gout outcomes in African-Americans (AAs). Methods In a 1-year, multicenter, randomized controlled trial, AA veterans with gout were randomized to gout-storytelling intervention vs. a stress reduction video (attention control group; 1:1 ratio). The primary outcome was ULT adherence measured with MEMSCap™, an electronic monitoring system that objectively measured ULT medication adherence. Results The 306 male AA veterans with gout who met the eligibility criteria were randomized to the gout-storytelling intervention (n = 152) or stress reduction video (n = 154); 261/306 (85%) completed the 1-year study. The mean age was 64 years, body mass index was 33 kg/m2, and gout disease duration was 3 years. ULT adherence was similar in the intervention vs. control groups: 3 months, 73% versus 70%; 6 months, 69% versus 69%; 9 months, 66% versus 67%; and 12 months, 61% versus 64% (p > 0.05 each). Secondary outcomes (gout flares, serum urate and gout-specific health-related quality of life [HRQOL]) in the intervention versus control groups were similar at all time points except intervention group outcomes were better for the following: (1) number of gout flares at 9 months were fewer, 0.7 versus 1.3 in the previous month (p = 0.03); (2) lower/better scores on two gout specific HRQOL subscales: gout medication side effects at 3 months, 32.8 vs. 39.6 (p = 0.02); and unmet gout treatment need at 3 months, 30.9 vs. 38.2 (p = 0.003), and 6 months, 29.5 vs. 34.5 (p = 0.03), respectively. Conclusions A culturally appropriate gout-storytelling intervention was not superior to attention control for improving gout outcomes in AAs with gout. Trial registration Registered at ClinicalTrials.gov NCT02741700

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