scholarly journals Effectiveness of a Multifactorial Intervention in the First 1000 Days of Life to Prevent Obesity and Overweight in Childhood: Study Protocol

2020 ◽  
Vol 17 (7) ◽  
pp. 2239
Author(s):  
Mercedes Díaz-Rodríguez ◽  
Celia Pérez-Muñoz ◽  
José Manuel Lendínez-de la Cruz ◽  
Martina Fernández-Gutiérrez ◽  
Pilar Bas-Sarmiento ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Later Life ◽  
Randomized Controlled ◽  
Early Programming ◽  
Obesity And Overweight ◽  
Data Collection Sheet ◽  
Ethical Approval ◽  
The Impact ◽  
Global Health Problem

(1) Background: Obesity is a global health problem, and its prevention must be a priority goal of public health, especially considering the seriousness of the problem among children. It is known that fetal and early postnatal environments may favor the appearance of obesity in later life. In recent years, the impact of the programs to prevent obesity in childhood has been scarce. The aim of this research is to evaluate the effectiveness of an intervention based on the concept of early programming. (2) Methods: Non-randomized controlled trial design. Inclusion criteria are: two-year-old infants whose gestational period begins in the 14 months following the start of the intervention, and whose mothers have made the complete follow-up of their pregnancy in the same clinical unit of the study. The intervention will be developed over all the known factors that affect early programming, during pregnancy up to 2 years of life. Data will be collected through a data collection sheet by the paediatricians. A unibivariate and multivariate analysis of the data will be carried out. (3) Ethics and dissemination: The trial does not involve any risk to participants and their offspring. Signed informed consent is obtained from all participants. Ethical approval has been obtained. (4) Results: It is expected that this study will provide evidence on the importance of the prevention of obesity from the critical period of the first 1000 days of life, being able to establish this as a standard intervention in primary care.

scholarly journals Does a tailored intervention to promote adherence in patients with chronic lung disease affect exacerbations? A randomized controlled trial

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Claudia Gregoriano ◽  
Thomas Dieterle ◽  
Anna-Lisa Breitenstein ◽  
Selina Dürr ◽  
Amanda Baum ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ambulatory Setting ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Copd Patients ◽  
The Impact ◽  
Inhaled Medication

Abstract Background Poor medication-adherence is common in chronic lung patients, resulting in reduced health-outcomes and increased healthcare-costs. This study aimed to investigate the impact of an acoustic reminder and support calls on adherence to inhaled therapy in asthma and COPD patients and to determine their effect on exacerbations. Methods This single-blinded randomized controlled trial investigated asthma and COPD patients during 6 months in an ambulatory setting. The intervention consisted of daily alarm clock and support phone calls, whenever use of rescue medication doubled or inhaled medication was not taken as prescribed. Primary outcome was time to next exacerbation. Frequency of exacerbations, adherence to inhaled medication and quality of life scores were secondary outcomes. Cox and Poisson regression were used to determine intervention effect on time to exacerbation and frequency of exacerbations, respectively. Results Seventy-five participants were assigned to the intervention group and 74 to usual follow-up care. During a median follow-up of 6.2 months, 22 and 28% in the intervention and control groups respectively, experienced at least one exacerbation. Intervention had no effect on time to first exacerbation (HR 0.65, 95% CI 0.21 to 2.07, P = .24), but showed a trend toward a 39% decreased frequency of exacerbations (RR = 0.61, 95% CI 0.35 to 1.03, P = .070) for the adjusted models, respectively. The intervention group had significantly more days with 80–100% taking adherence regarding puff inhalers (82 ± 14% vs. 60 ± 30%, P < .001) and dry powder capsules (90 ± .10% vs. 80 ± 21%, P = .01). Timing adherence in participants using puff inhalers was higher in the intervention group (69 ± 25% vs. 51 ± 33%, P < .001). No significant differences in QoL were found between the two groups. Conclusion Participants assigned to the intervention group had significantly better taking and timing adherence of inhaled medication resulting in a trend towards a decreased frequency of exacerbations. However, no effect on time to next exacerbation was observed. Trial registration ClinicalTrials.gov: NCT02386722, Registered 14 February 2014.

scholarly journals Implementation of a School Physical Activity Policy Improves Student Physical Activity Levels: Outcomes of a Cluster-Randomized Controlled Trial

2020 ◽  
Vol 17 (10) ◽  
pp. 1009-1018
Author(s):  
Nicole K. Nathan ◽  
Rachel L. Sutherland ◽  
Kirsty Hope ◽  
Nicole J. McCarthy ◽  
Matthew Pettett ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
School Day ◽  
Cluster Randomized ◽  
The Impact

Aim: To assess the impact of a multistrategy intervention designed to improve teachers’ implementation of a school physical activity (PA) policy on student PA levels. Methods: A cluster-randomized controlled trial was conducted in 12 elementary schools. Policy implementation required schools to deliver 150 minutes of organized PA for students each week via physical education, sport, or class-based activities such as energizers. Schools received implementation support designed using the theoretical domains framework to help them implement the current policy. Results: A total of 1,502 children in kindergarten to grade 6 participated. At follow-up compared with control, students attending intervention schools had, measured via accelerometer, significantly greater increases in school day counts per minute (97.5; 95% confidence interval [CI], 64.5 to 130.4; P < .001) and moderate to vigorous physical activity (MVPA) (3.0; 95% CI, 2.2–3.8, P < .001) and a greater decrease in sedentary time (−2.1; 95% CI, −3.9 to −0.4, P = .02) per school day. Teachers in intervention schools delivered significantly more minutes (36.6 min) of PA to their students at follow-up (95% CI, 2.7–70.5, P = .04). Conclusions: Supporting teachers to implement a PA policy improves student PA. Additional strategies may be needed to support teachers to implement activities that result in larger gains in student MVPA.

scholarly journals Impact of Medication Regimen Simplification on Medication Administration Times and Health Outcomes in Residential Aged Care: 12 Month Follow Up of the SIMPLER Randomized Controlled Trial

2020 ◽  
Vol 9 (4) ◽  
pp. 1053 ◽  
Author(s):  
Janet K. Sluggett ◽  
Ria E. Hopkins ◽  
Esa YH Chen ◽  
Jenni Ilomäki ◽  
Megan Corlis ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Medication Administration ◽  
Aged Care ◽  
Residential Aged Care ◽  
Medication Regimen ◽  
Term Care ◽  
Randomized Controlled ◽  
The Impact

In the SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER) cluster-randomized controlled trial, we evaluated the impact of structured medication regimen simplification on medication administration times, falls, hospitalization, and mortality at 8 residential aged care facilities (RACFs) at 12 month follow up. In total, 242 residents taking ≥1 medication regularly were included. Opportunities for simplification among participants at 4 RACFs were identified using the validated Medication Regimen Simplification Guide for Residential Aged CarE (MRS GRACE). Simplification was possible for 62 of 99 residents in the intervention arm. Significant reductions in the mean number of daily medication administration times were observed at 8 months (−0.38, 95% confidence intervals (CI) −0.69 to −0.07) and 12 months (−0.47, 95%CI −0.84 to −0.09) in the intervention compared to the comparison arm. A higher incidence of falls was observed in the intervention arm (incidence rate ratio (IRR) 2.20, 95%CI 1.33 to 3.63) over 12-months, which was primarily driven by a high falls rate in one intervention RACF and a simultaneous decrease in comparison RACFs. No significant differences in hospitalizations (IRR 1.78, 95%CI 0.57–5.53) or mortality (relative risk 0.81, 95%CI 0.48–1.38) over 12 months were observed. Medication simplification achieves sustained reductions in medication administration times and should be implemented using a structured resident-centered approach that incorporates clinical judgement.

The impact of an empowerment intervention on people with schizophrenia: Results of a randomized controlled trial

2017 ◽  
Vol 63 (3) ◽  
pp. 212-223 ◽  
Author(s):  
Abdalhadi Hasan ◽  
Mahmoud Musleh
Keyword(s):  
Randomized Controlled Trial ◽  
Psychiatric Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Post Intervention ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
The Impact

Aims: The aim of the study was to assess what empowerment intervention has on people with schizophrenia. Methods: A randomized controlled trial was carried out between November 2015 and May 2016 involving 112 participants who had been diagnosed with schizophrenia. Patients, who were 18 years and above diagnosed with Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V) schizophrenia or schizoaffective disorder from the outpatient mental health clinics in Jordan, were randomly assigned to take part in an intervention that consisted of receiving 6 weeks’ worth of information booklets, with face to face discussions, while receiving their usual medication or allocated treatment as usual. The participants were assessed at baseline, immediately after the intervention and at 3-month follow-up. The primary outcome was a change in the helplessness score. Secondary outcomes were psychiatric symptoms, recovery rate, empowerment and quality of life. Results: This study showed that people with schizophrenia in the intervention group showed more improvement in the helplessness score immediately post-intervention ( F = 74.53, p < .001) and at 3-month follow-up ( F = 75.56, p < .001), they reported significant improvements in all secondary outcomes. Conclusion: This study indicated that the empowering intervention was an effective intervention when integrated with treatment as usual.

scholarly journals MON-LB012 Long-Term Developmental Impact of Withholding Parenteral Nutrition in Pediatric-ICU: A 4-Year Follow-Up of the Pepanic Randomized Controlled Trial

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
An Jacobs ◽  
Karolijn Dulfer ◽  
Renate Eveleens ◽  
José Hordijk ◽  
Hanna Van Cleemput ◽  
...  
Keyword(s):  
Dna Methylation ◽  
Randomized Controlled Trial ◽  
Health Status ◽  
Parenteral Nutrition ◽  
Behavioral Problems ◽  
Controlled Trial ◽  
Cpg Sites ◽  
Randomized Controlled ◽  
The Impact

Abstract Aim: Between 2012-2015, the PEPaNIC randomized controlled trial, which included 1440 critically ill infants and children, showed that withholding parenteral nutrition during the first week in the pediatric intensive care unit (PICU) (late-PN), as compared with initiating supplemental PN early (early-PN), improved PICU outcomes (1) and improved neurocognitive development assessed 2 years later (2). The latter was explained by avoiding early-PN induced adversely altered DNA-methylation of 37 CpG sites (3). As a large number of patients were younger than 1 year of age at randomization and given that assessment of most neurocognitive domains is only possible from 4 years of age onwards, we performed a 4-year follow-up to determine the impact of late-PN versus early-PN on physical, neurocognitive, and emotional/behavioral development. This pre-planned, 4-year follow-up study of the 1440 PEPaNIC patients and of 369 matched healthy children was blinded for treatment allocation (ClinicalTrials.gov-NCT01536275). Methods: Studied clinical outcomes included anthropometrics, health status, parent/caregiver-reported executive functions, and emotional/behavioral problems, and clinical tests for intelligence, visual-motor integration, alertness, motor coordination and memory. Univariable and multivariable linear and logistic regression analyses adjusted for risk factors assessed the impact of late-PN versus early-PN on the outcomes and investigated a potential mediation role of the adversely altered DNA-methylation of 37 CpG sites previously shown to be evoked by late-PN as compared with early-PN (3). Results: Overall, at 4 years follow-up, patients (356 late-PN patients, 328 early-PN patients) could be tested neurocognitively. They revealed worse anthropometric, health status, neurocognitive and emotional/behavioral developmental outcomes than the healthy control children. Outcomes of late-PN patients were never worse than those of early-PN patients. In contrast, late-PN patients had fewer internalizing (P=0.042) and externalizing problems (P=0.046), and fewer total emotional/behavioral problems (P=0.007) than early-PN patients, which were normalized by late-PN. Avoiding the early-PN induced adversely altered DNA-methylation status of the 37 CpG sites statistically explained its impact on the behavioral outcomes. Conclusion: Four years after randomization to late-PN or early-PN in the PICU, late-PN did not show harm, and was found to protect against emotional/behavioral problems, with altered DNA-methylation as a potential biological mediator hereof. These data further support de-implementation of PN-use early during critical illness in infants and children. (1) Fivez et al. N Eng J Med 2016 (2) Verstraete et al. Lancet Respir Med 2019 (3) Guiza et al. Lancet Respir Med 2020 (in press)

scholarly journals The Impact of Automated Notification on Follow-up of Actionable Tests Pending at Discharge: a Cluster-Randomized Controlled Trial

2018 ◽  
Vol 33 (7) ◽  
pp. 1043-1051 ◽  
Author(s):  
Anuj K. Dalal ◽  
Adam Schaffer ◽  
Esteban F. Gershanik ◽  
Ranganath Papanna ◽  
Katyuska Eibensteiner ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

scholarly journals The Impact of Using a Larger Forearm Artery for Percutaneous Coronary Interventions on Hand Strength: A Randomized Controlled Trial

2021 ◽  
Vol 10 (5) ◽  
pp. 1099
Author(s):  
Pawel Lewandowski ◽  
Anna Zuk ◽  
Tomasz Slomski ◽  
Pawel Maciejewski ◽  
Bogumil Ramotowski ◽  
...  
Keyword(s):  
Coronary Angiography ◽  
Ultrasound Examination ◽  
Controlled Trial ◽  
Ulnar Artery ◽  
Coronary Intervention ◽  
Hand Strength ◽  
Randomized Controlled ◽  
Percutaneous Coronary ◽  
The Impact

(1) Background: The exact mechanism underlying hand strength reduction (HSR) after coronary angiography with transradial access (TRA) or transulnar access (TUA) remains unknown. (2) Methods: This study aimed to assess the impact of using a larger or smaller forearm artery access on the incidence of HSR at 30-day follow-up. This was a prospective randomized trial including patients referred for elective coronary angiography or percutaneous coronary intervention. Based on the pre-procedural ultrasound examination, the larger artery was identified. Patients were randomized to larger radial artery (RA) or ulnar artery (UA) or a group with smaller RA/UA. The primary endpoint was the incidence of HSR, while the secondary endpoint was the incidence of subjective HSR, paresthesia, and any hand pain. (3) Results: We enrolled 200 patients (107 men and 93 women; mean age 68 ± 8 years) between 2017 and 2018. Due to crossover between TRA and TUA, there were 57% (n = 115) patients in larger RA/UA and 43% (n = 85) patients in smaller RA/UA. HSR occurred in 29% (n = 33) patients in larger RA/UA and 47% (n = 40) patients in smaller RA/UA (p = 0.008). Subjective HSR was observed in 10% (n = 12) patients in larger RA/UA and 21% (n = 18) patients in smaller RA/UA (p = 0.03). Finally, paresthesia was noted in 7% (n = 8) patients in larger RA/UA and 22% (n = 15) in smaller RA/UA (p = 002). Independent factors of HSR were larger RA/UA (OR 0.45; 95% CI, 0.24–0.82; p < 0.01) and the use of TRA (OR 1.87; 95% CI, 1.01–34; p < 0.05). (4) Conclusions: The use of a larger artery as vascular access was associated with a lower incidence of HSR at 30-day follow-up.

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