scholarly journals Treatment of Childhood Obesity Based on Brazilian Dietary Guidelines Plus Energy Restriction (PAPPAS HUPE Study): Protocol for a Randomized Clinical Trial (Preprint)

2019 ◽  
Author(s):  
Joana Maia Brandao ◽  
Rosely Sichieri ◽  
Simone Augusta Ribas ◽  
Eliseu Verly-Jr ◽  
Rosangela Alves Pereira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Childhood Obesity ◽  
Randomized Clinical Trial ◽  
Sugar Content ◽  
Intervention Group ◽  
Dietary Guidelines ◽  
University Hospital ◽  
National Council ◽  
Educational Activities ◽  
Treatment Of Obesity

BACKGROUND The Food Guide for the Brazilian Population relies on natural or minimally processed foods mainly of plant origin such as beans and rice with low oil, salt, and sugar content and limited consumption of ultraprocessed foods. Reduction of ultraprocessed foods improves diet quality and energy consumption. OBJECTIVE The goal of this study is to evaluate the effectiveness of an intervention for the treatment of obesity in children, with counseling based on the Brazilian Food Guide plus control of total energy intake. METHODS A parallel, randomized clinical trial will include children aged 7 to 12 years. Randomization will be performed in blocks of 10 individuals using computer-generated random sequence numbers. Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide. These activities will be conducted at the University Hospital Toy Library, located in the pediatric outpatient clinic. For the intervention group, in addition to the educational activities, an individualized food plan based on the nutritional recommendations of the Brazilian Society of Pediatrics will be prescribed and discussed with the mothers and fathers. The primary outcome of the study will be variations in body mass index, and secondary outcomes will include analysis of insulin resistance, blood pressure, body fat percentage, and waist and neck circumference. RESULTS This project was funded by the National Council for Scientific and Technological Development in December 2017 (grant no 408333/2017-0). Recruitment began in August 2018 and by September 2019, we had enrolled the 101 participants. In addition to the patients referred by the national system of regulation, recruitment was made by medical outpatient referral and external indication. This is an ongoing study. We expect the results to be published in November 2020. CONCLUSIONS At the end of the project, in case of a positive result, a protocol for the treatment of obesity based on the Brazilian Food Guide will be proposed to the Unified Health System. A successful method to reduce childhood obesity is expected. CLINICALTRIAL Brazilian Registry of Clinical Trials RBR-3st5sn; http://www.ensaiosclinicos.gov.br/rg/RBR-3st5sn INTERNATIONAL REGISTERED REPORT DERR1-10.2196/16170

scholarly journals Treatment of Childhood Obesity Based on Brazilian Dietary Guidelines Plus Energy Restriction (PAPPAS HUPE Study): Protocol for a Randomized Clinical Trial

10.2196/16170 ◽  
2020 ◽  
Vol 9 (6) ◽  
pp. e16170
Author(s):  
Joana Maia Brandao ◽  
Rosely Sichieri ◽  
Simone Augusta Ribas ◽  
Eliseu Verly-Jr ◽  
Rosangela Alves Pereira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Childhood Obesity ◽  
Randomized Clinical Trial ◽  
Sugar Content ◽  
Intervention Group ◽  
Dietary Guidelines ◽  
University Hospital ◽  
National Council ◽  
Educational Activities ◽  
Treatment Of Obesity

Background The Food Guide for the Brazilian Population relies on natural or minimally processed foods mainly of plant origin such as beans and rice with low oil, salt, and sugar content and limited consumption of ultraprocessed foods. Reduction of ultraprocessed foods improves diet quality and energy consumption. Objective The goal of this study is to evaluate the effectiveness of an intervention for the treatment of obesity in children, with counseling based on the Brazilian Food Guide plus control of total energy intake. Methods A parallel, randomized clinical trial will include children aged 7 to 12 years. Randomization will be performed in blocks of 10 individuals using computer-generated random sequence numbers. Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide. These activities will be conducted at the University Hospital Toy Library, located in the pediatric outpatient clinic. For the intervention group, in addition to the educational activities, an individualized food plan based on the nutritional recommendations of the Brazilian Society of Pediatrics will be prescribed and discussed with the mothers and fathers. The primary outcome of the study will be variations in body mass index, and secondary outcomes will include analysis of insulin resistance, blood pressure, body fat percentage, and waist and neck circumference. Results This project was funded by the National Council for Scientific and Technological Development in December 2017 (grant no 408333/2017-0). Recruitment began in August 2018 and by September 2019, we had enrolled the 101 participants. In addition to the patients referred by the national system of regulation, recruitment was made by medical outpatient referral and external indication. This is an ongoing study. We expect the results to be published in November 2020. Conclusions At the end of the project, in case of a positive result, a protocol for the treatment of obesity based on the Brazilian Food Guide will be proposed to the Unified Health System. A successful method to reduce childhood obesity is expected. Trial Registration Brazilian Registry of Clinical Trials RBR-3st5sn; http://www.ensaiosclinicos.gov.br/rg/RBR-3st5sn International Registered Report Identifier (IRRID) DERR1-10.2196/16170

scholarly journals Chlorhexidine and gauze and tape dressings for central venous catheters: a randomized clinical trial

2014 ◽  
Vol 22 (5) ◽  
pp. 764-771 ◽  
Author(s):  
Edivane Pedrolo ◽  
Mitzy Tannia Reichembach Danski ◽  
Stela Adami Vayego
Keyword(s):  
Clinical Trial ◽  
Intensive Care ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Bloodstream Infections ◽  
Central Venous Catheters ◽  
University Hospital ◽  
Control Group ◽  
P Value ◽  
Central Venous

OBJECTIVE: to assess the effectiveness of the chlorhexidine antimicrobial dressing in comparison to the gauze and tape dressing in the use of central venous catheters.METHOD: a randomized clinical trial was conducted in the intensive care and adult semi intensive care units of a university hospital in the south of Brazil. The subjects were patients using short-term central venous catheters, randomly assigned to the intervention (chlorhexidine antimicrobial dressing) or control (gauze and micro porous tape) groups.RESULTS: a total of 85 patients were included: 43 in the intervention group and 42 in the control group. No statistically significant differences were found between dressings in regard to the occurrence of: primary bloodstream infections (p-value = 0.5170); local reactions to the dressing (p-value = 0.3774); and dressing fixation (p-value = 0.2739).CONCLUSION: both technologies are effective in covering central venous catheters in regard to the investigated variables and can be used for this purpose. Registry ECR: RBR-7b5ycz.

Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial

2021 ◽  
pp. 1357633X2110096
Author(s):  
Maria KEF Feijó ◽  
Karen Brasil Ruschel ◽  
Daniela Bernardes ◽  
Eduarda B Ferro ◽  
Luis E Rohde ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Heart Association ◽  
Functional Class ◽  
Emergency Department Visits ◽  
Control Group ◽  
Point Change ◽  
Clinical Instability

Introduction The aim of this study was to evaluate the effectiveness of a diuretic adjustment algorithm (DAA) in maintaining clinical stability and reducing HF readmissions using telemonitoring Technologies. Methods Randomized clinical trial of patients with an indication for furosemide dose adjustment during routine outpatient visits. In the intervention group (IG), the diuretic dose was adjusted according to the DAA and the patients received telephone calls for 30 days. In the control group (CG), the diuretic dose was adjusted by a physician at baseline only. Co-primary outcomes were hospital readmission and/or emergency department visits due to decompensated HF within 90 days, and a 2-point change in the Clinical Congestion Score and/or a deterioration in New York Heart Association functional class within 30 days. Results A total of 206 patients were included. Most patients were male ( n=119; 58%), with a mean age of 62 (SD 13) years. Four patients (2%) in the IG and 14 (7%) in the CG were hospitalized for HF (odds ratio (OR) 0.31 (0.10–0.91); p=0.04). Multivariate analysis showed a reduction of 67% in readmissions and/or emergency department visits due to decompensated HF in the IG compared with the CG (95% CI 0.13–0.88; p=0.027). Regarding the combined outcome of HF readmission and/or emergency department visits or clinical instability, the IG had 20% fewer events than the CG within 30 days (IG: n=48 (23%), CG: n=70 (34%); OR 0.80 (0.63–0.93); p=0.03). Discussion Using DAA improved the combined outcome in these outpatients, with favorable and significant results that included a reduction in HF admissions and in clinical instability. (NCT02068937)

scholarly journals Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

2020 ◽  
Author(s):  
Pedro Acién ◽  
Irene Velasco ◽  
Maribel Acién
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Transvaginal Ultrasound ◽  
Intrauterine Device ◽  
Conservative Surgery ◽  
University Hospital ◽  
Ca 125 ◽  
Fertility Sparing ◽  
Ultrasound Guided Puncture ◽  
Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences. Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019). Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.

scholarly journals Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

2020 ◽  
Author(s):  
Pedro Acién ◽  
Irene Velasco ◽  
Maribel Acién
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Transvaginal Ultrasound ◽  
Intrauterine Device ◽  
Conservative Surgery ◽  
University Hospital ◽  
Ca 125 ◽  
European Medicines Agency ◽  
Fertility Sparing ◽  
Ultrasound Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences.Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019).Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.Details of trial registration: Eudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.

scholarly journals Effect of Acupressure on Stress and Anxiety of Patients with Multiple Sclerosis: A Sham-controlled Randomized Clinical Trial

2020 ◽  
Vol 10 (3) ◽  
pp. 270-283
Author(s):  
Mohammad Ali Nahayati ◽  
◽  
Seyed Abolfazl Vaghar Seyyedin ◽  
Hamid Reza Bahrami-Taghanki ◽  
Zahra Rezaee ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Test Scores ◽  
Sham Group ◽  
Applied Pressure ◽  
Intervention Group ◽  
T Test ◽  
Significant Difference ◽  
The Mean

Objective: Stress and anxiety are common in patients with Multiple Sclerosis (MS). These complications exacerbate the symptoms of MS. This study aims to evaluate the effect of acupressure on stress and anxiety of MS patients. Methods: In this randomized clinical trial, participants were 106 MS Patients referred to Multiple Sclerosis Society in Mashhad, Iran. After signing an informed consent form, they completed a demographic form and stress, and the Depression Anxiety Stress Scale - 42 items (DASS-42). Then, they were randomly assigned into intervention and sham groups by tossing a coin. Participants in the intervention group were asked apply a pressure on the Shenmen and Yin Tang acupoints for one month (once per day for 15 minutes), while the sham group applied pressure 2.5 cm below the Shenmen acupoint and 3 cm above the Yin Tang acupoint. Participants in each group were then completed the DASS-42 again one hour after the final session. Data were analyzed using chi-square test, Kolmogorov-Smirnov test, independent t-test, and Paired t-test. Results: In the intervention and sham groups, there was no statistically significant difference between the mean pre-test scores of stress (34.73±5.80 vs. 33.06±6.42) and anxiety (27.09±6.99 vs. 25.31±6.88), and neither between the mean post-test scores of stress (29.20±6.21 vs. 33.73±9.44) and anxiety (22.79±5.68 vs. 25.21±6.72) (P>0.05). However, comparison of DASS-42 scores between groups showed that the mean scores of stress and anxiety in the intervention group were significantly lower than in the sham group (P< 0.05). Conclusion: It seems that acupressure can be used along with other therapeutic and pharmacological interventions to reduce stress and anxiety in patients with MS.

Hyperuricemia in a Child: A Complication of Treatment of Obesity

PEDIATRICS ◽  
1974 ◽  
Vol 54 (3) ◽  
pp. 370-371
Author(s):  
George Mathew ◽  
Fima Lifshitz
Keyword(s):  
Case Report ◽  
Childhood Obesity ◽  
Initial Period ◽  
Normal Pregnancy ◽  
University Hospital ◽  
Management Problem ◽  
White Girl ◽  
North Shore ◽  
Low Carbohydrate ◽  
Treatment Of Obesity

Childhood obesity has become an important management problem for the practicing pediatrician. Carbohydrate restrictive diets are being utilized in treatment with increasing frequency in recent years.1,2 Hyperuricemia during carbohydrate deprivation is a well-documented entity in adults,3,4 but has not been reported in children. In the following report we describe a child who developed severe hyperunicemia following a low-carbohydrate ketogenic regimen during the initial period of treatment of obesity. CASE REPORT R. F., a 10-year-old white girl, was admitted to North Shore University Hospital for management of severe exogenous obesity. She was the product of a normal pregnancy and uncomplicated delivery, and weighed 2,660 kg at birth.

scholarly journals The Obemat2.0 Study: A Clinical Trial of a Motivational Intervention for Childhood Obesity Treatment

Nutrients ◽  
2019 ◽  
Vol 11 (2) ◽  
pp. 419 ◽  
Author(s):  
Veronica Luque ◽  
Albert Feliu ◽  
Joaquín Escribano ◽  
Natalia Ferré ◽  
Gemma Flores ◽  
...  
Keyword(s):  
Physical Activity ◽  
Primary Care ◽  
Clinical Trial ◽  
Childhood Obesity ◽  
Intervention Group ◽  
Fat Free Mass ◽  
Z Score ◽  
Motivational Intervention ◽  
Mineral Density ◽  
Post Intervention

The primary aim of the Obemat2.0 trial was to evaluate the efficacy of a multicomponent motivational program for the treatment of childhood obesity, coordinated between primary care and hospital specialized services, compared to the usual intervention performed in primary care. This was a cluster randomized clinical trial conducted in Spain, with two intervention arms: motivational intervention group vs. usual care group (as control), including 167 participants in each. The motivational intervention consisted of motivational interviewing, educational materials, use of an eHealth physical activity monitor and three group-based sessions. The primary outcome was body mass index (BMI) z score increments before and after the 12 (+3) months of intervention. Secondary outcomes (pre-post intervention) were: adherence to treatment, waist circumference (cm), fat mass index (z score), fat free mass index (z score), total body water (kg), bone mineral density (z score), blood lipids profile, glucose metabolism, and psychosocial problems. Other assessments (pre and post-intervention) were: sociodemographic information, physical activity, sedentary activity, neuropsychological testing, perception of body image, quality of the diet, food frequency consumption and foods available at home. The results of this clinical trial could open a window of opportunity to support professionals at the primary care to treat childhood obesity. The clinicaltrials.gov identifier was NCT02889406.

Effect of prenatal recommendations of Traditional Persian Medicine on obstetric outcomes: a randomized clinical trial

2018 ◽  
Vol 15 (3) ◽  
Author(s):  
Mansoor Keshavarz ◽  
Maryam Kashanian ◽  
Soodabeh Bioos ◽  
Yasaman Vazani
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Active Phase ◽  
Obstetric Outcomes ◽  
Control Group ◽  
Control Groups ◽  
Persian Medicine ◽  
Traditional Persian Medicine ◽  
And Control

Abstract Background Traditional Persian Medicine (TPM) is an ancient medical system that provides suggestions to improve the health of mothers and children during pregnancy and labor. Persian physicians believed that these instructions made labor easier, safer, and less painful. Methods The present randomized clinical trial was conducted among women at 33–38 weeks of pregnancy in Tehran, Iran. TPM instructions consisted of diet, bathing, and application of oil from the 38th week of pregnancy to the onset of labor. The primary outcome was the duration of the active phase of labor. Results The mean duration of the active phase was 331.60 ± 151.48 min for the intervention group and 344.40 ± 271.46 min for the control groups, but it was not statistically significant. The active phase was significantly shorter in women who had better compliance (p=0.03). The need for oxytocin augmentation was 53.3% in the control group and 38.5% in the intervention group (p=0.17). The rate of perineal infection was 13% in the control group and 0% in the intervention group (p=0.11). Conclusions The active phase was not different in the intervention and control groups, but it was shorter in compliant women. It is possible that prolonged use of these recommendations in combination with a sitz baths and a larger sample size could result in more significant outcomes.

scholarly journals The Effect of Support Surfaces on the Incidence of Pressure Injuries in Critically Ill Patients: A Randomized Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Wesley Henrique Bueno de Camargo ◽  
Rita de Cassia Pereira ◽  
Marcos T. Tanita ◽  
Lidiane Heko ◽  
Isadora C Grion ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Intervention Group ◽  
Control Group ◽  
Support Surface ◽  
Intention To Treat ◽  
Support Surfaces ◽  
Effect Of Support

Purpose. To analyze whether a viscoelastic mattress support surface can reduce the incidence of stage 2 pressure injuries compared to a standard hospital mattress with pyramidal overlay in critically ill patients. Method. A randomized clinical trial with intention-to-treat analysis was carried out recruiting patients with Braden scale ≤14 on intensive care unit admission from April 2016 to April 2017. Patients were allocated into two groups: intervention group (viscoelastic mattress) and control group (standard mattress with pyramidal overlay). The level of significance adopted was 5%. Results. A total of 62 patients were included in the study. There was a predominance of males (53%) and the mean age was 67.9 (SD 18.8) years. There were no differences in clinical or severity characteristics between the patients in the control group and the intervention group. Pressure injuries occurred in 35 patients, with a median time of 7 days (ITQ 4–10) from admission. The frequency of pressure injuries was higher in the control group (80.6%) compared to the intervention group (32.2%; p<0.001). Conclusions. Viscoelastic support surfaces reduced the incidence of pressure injuries in moderate or higher risk critically ill patients when compared to pyramidal support surfaces.

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