scholarly journals Protocol for a randomised controlled trial on the feasibility and effects of 10-hour time-restricted eating on cardiometabolic disease risk among career firefighters doing 24-hour shift work: the Healthy Heroes Study

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e045537
Author(s):  
Emily N C Manoogian ◽  
Adena Zadourian ◽  
Hannah C Lo ◽  
Nikko R Gutierrez ◽  
Azarin Shoghi ◽  
...  

Introduction Career firefighters experience chronic circadian rhythm disruption, increasing their risk of cardiometabolic disease. The recent discovery that eating patterns regulate circadian rhythmicity in metabolic organs has raised the hypothesis that maintaining a consistent daily cycle of eating and fasting can support circadian rhythms and reduce disease risks. Preclinical animal studies and preliminary clinical trials have shown promising effects of time-restricted eating (TRE) to reduce disease risk without compromising physical performance. However, there is a lack of research on TRE in shift workers including firefighters. This study aims to investigate the feasibility and efficacy of 10-hour TRE on health parameters that contribute to cardiometabolic disease risks among career firefighters who work on a 24-hour shift schedule. Methods and analyses The Healthy Heroes Study is a randomised controlled parallel open-label clinical trial with 150 firefighters over 1 year. Firefighters are randomised with a 1:1 ratio to either the control or intervention group. The control group receives Mediterranean diet nutritional counselling (standard of care, ‘SOC’). The intervention group receives the same SOC and a self-selected 10-hour TRE window. After the 2-week baseline, participants enter a 3-month monitored intervention, followed by a 9-month self-guided period with follow-up assessments. The impact of TRE on blood glucose, body weight, body composition, biomarkers (neuroendocrine, inflammatory and metabolic), sleep and mood is evaluated. These assessments occur at baseline, at the end of intervention and at 6, 9 and 12-month follow-ups. Temporal calorie intake is monitored with the smartphone application myCircadianClock throughout the study. Continuous glucose monitors, wrist-worn actigraphy device and questionnaires are used to monitor glucose levels, activity, sleep and light exposure. Ethics and dissemination The study was approved by the Institutional Review Boards of the University of California San Diego and the Salk Institute for Biological Studies. Results will be disseminated through peer-reviewed manuscripts, reports and presentations. Trial registration number NCT03533023; Pre result.

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513


2021 ◽  
Vol 19 (Sup9) ◽  
pp. S30-S37
Author(s):  
Eugenia Rodriguez González ◽  
Carmen del Pino Zurita ◽  
Gemma Arrontes Caballero ◽  
Araceli Hoyo Rodríguez ◽  
Eugenia Zapatero Rodríguez ◽  
...  

Aim: The Convexity in Ostomy (ECOS) study measured the impact of soft convex ostomy appliances on leakage frequency, peristomal skin health, and patient satisfaction, as well as stomal protrusion and body profile. Methods: This prospective non-randomised controlled trial included people with a stoma, divided into a control group using a convex appliance throughout (Alterna Confort Convex or Easiflex Confort Convex Light, Coloplast A/S, Humlebæk, Denmark), and an intervention group who were using a flat appliance at baseline before switching to a convex appliance for the rest of the study. Leakage frequency was counted within the past 2 weeks; peristomal skin health was assessed using the discolouration, erosion and tissue overgrowth (DET) Ostomy Skin Tool; and patient satisfaction was measured with a 0-10 Likert scale of self-reported satisfaction with the appliance. Measurements were taken at three visits: baseline (V1), 2-8 weeks (V2) and 6 months (V3). The Kruskal-Wallis and analysis of variance (ANOVA) tests were used for comparison. Multiple regression analysis was used to evaluate the effect of independent variables on the change in leakage frequency and DET score between baseline and 6 months. Findings: Of 253 participants screened, 245 completed the follow-up, with 151 in the intervention group and 94 in the control group. Mean leakage frequency period went from 5.85 ± 5.55 (V1) to 0.63 ± 1.42 (V2) and 0.23 ± 0.75 (V3) (p<.0001). Mean DET score changed from 4.8 ± 3.47 (V1) to 1.41 ± 2.17 (V2) and 0.54 ± 1.57 (V3) (p<.0001). Mean satisfaction changed from 6.0 ± 2.25 (V1) to 8.6 ± 1.14 (V2) and 9.17 ± 0.93 (V3) (p<.0001). From V1 to V3, the proportion of patients with a depressed peristomal area went from 45.7% to 31.4%, a normal peristomal area went from 45.3% to 65.3%, stoma protrusion went from 31.4% to 47.3% and stoma retraction went from 28.6% to 15.5%. By group, mean leakage frequency decreased in the intervention group by 7.65, from 7.57 to 0.11, and in the control group by 2.37, from 2.94 to 0.46 (p<0.0001). Multiple ANOVA analysis confirmed independent variables in reducing leakage to be initiating convexity and appliance coupling. By group, mean DET score decreased in the intervention group by 4.82, from 5.24 to 0.42, and in the control group by 3.52, from 4.34 to 0.76. Multiple ANOVA analysis showed independent variables for DET score to be initiating convexity, emergency surgery and stoma siting. Conclusion: People with a stoma experiencing repeated leakage benefitted from shifting from a flat to a soft convex appliance in terms of leakage frequency, peristomal skin health, stomal protrusion and body profile.


BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e036799 ◽  
Author(s):  
David Blanco ◽  
Sara Schroter ◽  
Adrian Aldcroft ◽  
David Moher ◽  
Isabelle Boutron ◽  
...  

ObjectiveTo evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials.DesignRandomised controlled trial (RCT).SettingBMJ Open’s quality improvement programme.Participants24 manuscripts describing RCTs.InterventionsWe used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review.OutcomesThe primary outcome is the number of adequately reported items (0–8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention.ResultsManuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min.ConclusionsWe demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability.Trial registration numberNCT03751878.


2021 ◽  
pp. bjophthalmol-2020-318049
Author(s):  
William H Dean ◽  
John Buchan ◽  
Stephen Gichuhi ◽  
Heiko Philippin ◽  
Simon Arunga ◽  
...  

Background/AimGlaucoma accounts for 8% of global blindness and surgery remains an important treatment. We aimed to determine the impact of adding simulation-based surgical education for glaucoma.MethodsWe designed a randomised controlled, parallel-group trial. Those assessing outcomes were masked to group assignment. Fifty-one trainee ophthalmologists from six university training institutions in sub-Saharan Africa were enrolled by inclusion criteria of having performed no surgical trabeculectomies and were randomised. Those randomised to the control group received no placebo intervention, but received the training intervention after the initial 12-month follow-up period. The intervention was an intense simulation-based surgical training course over 1 week. The primary outcome measure was overall simulation surgical competency at 3 months.ResultsTwenty-five were assigned to the intervention group and 26 to the control group, with 2 dropouts from the intervention group. Forty-nine were included in the final intention-to-treat analysis. Surgical competence at baseline was comparable between the arms. This increased to 30.4 (76.1%) and 9.8 (24.4%) for the intervention and the control group, respectively, 3 months after the training intervention for the intervention group, a difference of 20.6 points (95% CI 18.3 to 22.9, p<0.001). At 1 year, the mean surgical competency score of the intervention arm participants was 28.6 (71.5%), compared with 11.6 (29.0%) for the control (difference 17.0, 95% CI 14.8 to 19.4, p<0.001).ConclusionThese results support the pursuit of financial, advocacy and research investments to establish simulation surgery training units and courses including instruction, feedback, deliberate practice and reflection with outcome measurement to enable trainee glaucoma surgeons to engage in intense simulation training for glaucoma surgery.Trial registration numberPACTR201803002159198.


BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029225 ◽  
Author(s):  
Elizabeth Webb ◽  
Teresa Neeman ◽  
Jamie Gaida ◽  
Francis J Bowden ◽  
Virginia Mumford ◽  
...  

IntroductionCellulitis represents a significant burden to patients’ quality of life (QOL) and cost to the healthcare system, especially due to its recurrent nature. Chronic oedema is a strong risk factor for both an initial episode of cellulitis and cellulitis recurrence. Expert consensus advises compression therapy to prevent cellulitis recurrence in individuals with chronic oedema, however, there is little supporting evidence. This research aims to determine if the management of chronic oedema using compression therapy effectively delays the recurrence of lower limb cellulitis.Methods and analysisA randomised controlled trial with cross-over will be used to assess the impact of compression therapy on clinical outcomes (time to next episode of cellulitis, rate of cellulitis-related hospital presentations, QOL and leg volume). Using concealed allocation, 162 participants will be randomised into the intervention (compression) or control (no compression) group. Randomisation will be stratified by prophylactic antibiotic use. Participants will be followed up at 6 monthly intervals for up to 3 years or until 45 episodes of cellulitis occur across the cohort. Following an episode of recurrent cellulitis, control group participants will cross-over to the intervention group. Survival analysis will be undertaken to assess the primary outcome measure of time to cellulitis recurrence. The hypotheses are that compression therapy to control lower limb chronic oedema will delay recurrent lower limb cellulitis, reduce the rate of associated hospitalisations, minimise affected limb volume and improve the QOL of this population.Ethics and disseminationEthics approval has been obtained from the ethics committees of all relevant institutions. Results will be disseminated through relevant peer-reviewed journal articles and conference presentations.Trial registration numberACTRN12617000412336; Pre-results. The ICTOC trial is currently in progress. Participant recruitment started in May 2017 and is expected to continue until December 2019.


2020 ◽  
pp. 1-9
Author(s):  
Lisa Afonso ◽  
Sara Aboim ◽  
Patrícia Pessoa ◽  
Xana Sá-Pinto

Abstract Objective: To determine the impact of an educational programme for primary schools that explored the biodiversity of tomato, by promoting science and sensory education with three distinct varieties of it, in the acceptance of vegetables. Design: A randomised controlled study in which children were exposed to the educational programme (intervention group) or remained in the class, as usual (control group). The educational programme consisted of three sessions where children explained the observed differences between the three varieties of tomato and individual perceptions of their flavours based on sensory-based food education and by planning and implementing experiments to explain those differences. We tested the effects on both children’s willingness to try and their liking for tomato, and for lettuce and cabbage to study the carry-over effect, compared with the control group (Mann–Whitney U test; P < 0·05). Setting: The study took place in public primary schools in Porto, Portugal. Participants: Children in the third grade (8–13-year-old children) (n 136) were randomly assigned to intervention or control group. Results: Children in the intervention group reported significant increases in their willingness to try and liking for tomato compared to the control group (P < 0·05), but not for lettuce and cabbage (P > 0·05). Conclusions: These results highlight the potential for fostering children’s acceptance of a vegetable by exploring biodiversity through science education. Further work may clarify the effects of exploring biodiversity on the consumption of vegetables and establish whether the results are stable over time and replicable across contexts and populations.


2019 ◽  
Author(s):  
Stéphane Sanchez ◽  
Cécile Payet ◽  
Marie Herr ◽  
Anne Dazinieras ◽  
Caroline Blochet ◽  
...  

BACKGROUND The elderly are particularly exposed to adverse events from medication. Among the various strategies to reduce polypharmacy, educational approaches have shown promising results. OBJECTIVE We aimed to evaluate the impact of the implementation of a good medical practice booklet on polypharmacy in nursing homes. METHODS We identified nursing homes belonging to a geriatric care provider that had launched a policy of proper medication use using a good medical practice booklet delivered to prescribers and pharmacists. Data were derived from electronic pill dispensers. The effect of the intervention on polypharmacy was assessed with multilevel regression models, with a control group to account for natural trends over time. The main outcomes were the average daily number of times when medication was administered and the number of drugs with different presentation identifier codes per resident per month. RESULTS 96,216 residents from 519 nursing homes were included between 1 January 2011 and 31 December 2014. The intervention group and the control group both decreased their average daily use of medication (-0.05 and -0.06). The good medical practice booklet did not have a statistically significant effect (exponentiated difference-in-differences coefficient 1.00, 95% confidence interval 0.99-1.02, P=.45). CONCLUSIONS Although the good medical practice booklet itself did not seem effective in decreasing medication use, our data show the effectiveness of a higher-level policy to decrease polypharmacy.


Pharmacy ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 86
Author(s):  
Fauna Herawati ◽  
Yuni Megawati ◽  
Aslichah ◽  
Retnosari Andrajati ◽  
Rika Yulia

The long period of tuberculosis treatment causes patients to have a high risk of forgetting or stopping the medication altogether, which increases the risk of oral anti-tuberculosis drug resistance. The patient’s knowledge and perception of the disease affect the patient’s adherence to treatment. This research objective was to determine the impact of educational videos in the local language on the level of knowledge, perception, and adherence of tuberculosis patients in the Regional General Hospital (RSUD) Bangil. This quasi-experimental study design with a one-month follow-up allocated 62 respondents in the intervention group and 60 in the control group. The pre- and post-experiment levels of knowledge and perception were measured with a validated set of questions. Adherence was measured by pill counts. The results showed that the intervention increases the level of knowledge of the intervention group higher than that of the control group (p-value < 0.05) and remained high after one month of follow-up. The perceptions domains that changed after education using Javanese (Ngoko) language videos with the Community Based Interactive Approach (CBIA) method were the timeline, personal control, illness coherence, and emotional representations (p-value < 0.05). More than 95% of respondents in the intervention group take 95% of their pill compared to 58% of respondents in the control group (p-value < 0.05). Utilization of the local languages for design a community-based interactive approach to educate and communicate is important and effective.


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e037999
Author(s):  
Martina Rimmele ◽  
Jenny Wirth ◽  
Sabine Britting ◽  
Thomas Gehr ◽  
Margit Hermann ◽  
...  

IntroductionIn Germany, an efficient and feasible transition from hospital to home for older patients, ensuring continuous care across healthcare settings, has not yet been applied and evaluated. Based on the transitional care model (TCM), this study aims to reduce preventable readmissions of patients ≥75 years of age with a transitional care intervention performed by geriatric-experienced care professionals. The study investigates whether the intervention ensures continuous care during transition and stabilises the care situation of patients at home.Methods and analysesRandomised controlled clinical trial, recruiting between 25 April 2018 and 31 December 2019 in one German hospital in the city of Regensburg. The intervention group is supported by care professionals in the transition process from hospital to home for up to 12 months. Based on TCM, the intervention includes an individual care plan according to a patient’s symptoms, risks, needs and values. The plan is advanced in the domestic situation via personal visits and telephone contacts. All necessary care actions regarding, for example, mobility, residence adjustments, or nutrition, are initiated to be executed by ambulant care services, and are monitored, evaluated and adapted if necessary. In supervising the care plan, the care professionals do not administer active care services themselves but coordinate them. Patients and their caregivers are actively engaged in the care planning and execution. In contrast, the control group receives only usual discharge planning in the hospital and usual ambulatory care.The primary outcome is the all-cause readmission rate assessed using health insurance data within a follow-up of up to 12 months after hospital discharge. Secondary outcomes include care quality, mobility, nutritional and wound situation, and health-related quality of life. They are assessed at baseline, after 1 month, 3 months, 6 months, and at the end of study visit. Additionally, the economic efficiency of the intervention will be evaluated.Ethics and disseminationEthics approval for the trial was obtained from the Ethics Committee of the Friedrich-Alexander-Universität Erlangen-Nürnberg. Results will be published in peer-reviewed, open-access scientific journals and disseminated at national and international research conferences and through public presentations in the geriatric and healthcare community.Trial registrationClinicalTrials.gov identifier: NCT03513159.


2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo

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.


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