The design and rationale of an interdisciplinary, non-prescriptive, and Health at Every Size®-based clinical trial: The “Health and Wellness in Obesity” study

2017 ◽  
Vol 23 (4) ◽  
pp. 261-270 ◽  
Author(s):  
Mariana D Ulian ◽  
Bruno Gualano ◽  
Fabiana B Benatti ◽  
Patricia Lopes de Campos-Ferraz ◽  
Desire Coelho ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Exercise Program ◽  
Activity Level ◽  
Control Group ◽  
Obese Women ◽  
Structured Interviews ◽  
Post Intervention ◽  
Health At Every Size ◽  
Group I

Background: This manuscript describes the design and rationale of a clinical trial that aims to investigate the multiple physiological, attitudinal, nutritional, and behavioral effects of a new interdisciplinary intervention based on the Health at Every Size® (HAES®) approach in obese women. Methods: This will be a prospective, 7-month, randomized (2:1), mixed-method clinical trial. Obese women will be recruited and randomly allocated into two groups. The intervention group (I-HAES®; proposed n = 40) will undertake a novel HAES®-based intervention. Participants will take part in an exercise program, nutrition counseling sessions, and philosophical workshops, all aligned with the principles of the HAES® approach. The control group (CTRL; proposed n = 20) will participate in a program using a traditional HAES®-based group format, characterized by bimonthly lectures about the same topics offered to the experimental group, encouraging the adoption of a healthy lifestyle. The following multiple quantitative outcomes will be assessed pre and post intervention: health-related quality of life, cardiovascular risk factors, anthropometric assessments, physical activity level, physical capacity and function, and psychological and behavioral assessments. Qualitative analysis will be used to evaluate the experiences of the participants throughout the intervention, as assessed by focus groups and semi-structured interviews. Conclusions: The interdisciplinary research team leading this study has varied and complementary expertise. The knowledge arising from this study will help to guide new interdisciplinary interventions with the potential to holistically improve the health of obese individuals. This trial is registered at Clinicaltrials.gov (NCT02102061).

scholarly journals Revisit the Effectiveness of Educational Kinesiology on Stress and Anxiety Amelioration in Kindergarteners With Special Needs: A Nonrandomized Trial

2021 ◽  
Author(s):  
Pui Lun Alan TAI ◽  
Kwok Wai Way LAU
Keyword(s):  
Clinical Trial ◽  
Special Needs ◽  
Scientific Evidence ◽  
Intervention Group ◽  
Control Group ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Post Intervention ◽  
Educational Kinesiology ◽  
Registration Number

Abstract Although educational kinesiology is a popular intervention aims to improve brain functioning via physical movements, it lacks supporting scientific evidence. This study explores the effect of educational kinesiology on the changes in stress and anxiety markers in kindergarteners with special needs using psychometrics and biological measures. This open label non-randomized clinical trial was registered retrospectively in the Chinese Clinical Trial Registry (registration number: ChiCTR2000036305, url: http://www.chictr.org.cn/showproj.aspx?proj=58067, registration date: 22/08/2020). Thirty-seven kindergarteners with special needs (3.5-6.5 years old) were assigned to either the intervention group, which received one-hour educational kinesiology intervention weekly for a total of 10 weeks, or the wait-list control group. Scores of Parent-rated Preschool Anxiety Scale (PAS-TC), salivary cortisol and oxytocin levels were obtained pre- and post-intervention. After controlling baseline, the changes in oxytocin levels remained significantly different between groups (F1,35 = 5.590, p = 0.020, eta2 = 0.145), but not in cortisol levels (F1,35 = 0.364, p = 0.550, eta2 = 0.01). PAS-TC showed significant improvement in anxiety levels after the intervention in the intervention group (X2 = 4.367, p = 0.037, φ = 0.344, p = 0.037). Findings from both subjective and objective measures indicate a plausible anti-stress and anxiety effect in kindergarteners with special needs.

scholarly journals Evaluation of the Effect of Atorvastatin Administration on the Outcomes of Patients with Traumatic Brain Injury: A Double-Blinded Randomized Clinical Trial

2021 ◽  
Vol 11 (4) ◽  
Author(s):  
Farhad Soltani ◽  
Farahzad Janatmakan ◽  
Sara Jorairahmadi ◽  
Fatemeh Javaherforooshzadeh ◽  
Pooyan Alizadeh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Randomized Clinical Trial ◽  
Rating Scale ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Disability Rating Scale ◽  
Double Blinded

Background: Traumatic brain injury (TBI) is one of the common causes of long-term disabilities and mortality. This study aimed to evaluate the effect of atorvastatin administration on the Glasgow Coma Scale (GCS), Glasgow Outcome Scale (GOS), and Disability Rating Scale (DRS) in patients with TBI. Methods: This double-blinded randomized clinical trial included 60 patients with TBI in Golestan Hospital of Ahvaz, Iran. After obtaining an informed consent from all patients, the patients were randomly assigned into two groups. For the intervention group, atorvastatin with a daily dose of 20 mg was used. The control group was administered the same amount of placebo for 10 days. Changes in the level of consciousness were measured using the GCS, and functional recovery rate in patients was measured by GOS and DRS in the third follow-up month. Results: According to the obtained results, compared with the control group, the atorvastatin administration significantly increased the level of GCS and DRS within 2 - 3 months post-intervention and improved GOS since the tenth day after the study (P < 0.05). Conclusions: The results revealed the positive effect of atorvastatin on the improvement of outcomes measurements such as GCS, DRS, and GOS in patients after moderate and severe TBI.

scholarly journals Voices 2: Improving Prosodic Recognition in Schizophrenia With an Online Rehabilitation Program

2021 ◽  
Vol 12 ◽  
Author(s):  
María Lado-Codesido ◽  
Rosa María Rey Varela ◽  
Marina Larios Quiñones ◽  
Luis Martínez Agulleiro ◽  
Julieta Ossa Basanes ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emotion Recognition ◽  
Intervention Group ◽  
Rehabilitation Program ◽  
Clinical State ◽  
Control Group ◽  
Post Intervention ◽  
Clinical Trial Registration ◽  
Training Tool ◽  
On Line

Introduction: Emotion recognition of voices may play an important role in interpersonal communication and patients with schizophrenia present alterations in this regard. Several on-line rehabilitation tools have been developed for treatment in this area. Voices is an on-line prosodic recognition program consisting of identifying different emotional tones in neutral phrases, in different sessions of gradually increasing difficulty. This training tool has previously reported benefits, and a new version has been created called Voices 2. The main aim of this study is to test the capacity of the Voices 2 program to improve emotion recognition through prosody for adults with schizophrenia. Secondly, it seeks to observe durability effects 1 month after intervention.Method: A randomized, single-blind, multicenter clinical trial was conducted with 44 outpatients diagnosed with schizophrenia or schizoaffective disorder. The intervention group (also called Voices) was treated with Voices 2, whereas the control group was treated with auditory training that was not related to emotions. Sociodemographic and clinical data, clinical state (PANSS), Intelligence Quotient and prosodic recognition (RMV-SV) were measured at baseline. After intervention, RMV-SV and PANSS were assessed. One month later, the RMV-SV measure was repeated.Results: The control group (n = 19) and the Voices group (n = 22) did not differ on χ2, t or U tests in sociodemographic, clinical and psychometric variables at baseline or post-intervention (all p-values &gt; 0.05). In the Voices group, statistically significant differences were observed in the RMV-SV scale applied post-intervention vs. that applied pre-intervention (Z = 2.47, p = 0.013). Similar results were observed in the 1-month follow-up RMV-SV vs. the pre-intervention RMV-SV (Z = 1.97, p = 0.049). PANSS scale was also assessed with no significant differences between pre vs. post measures in both groups. Lastly, Voices 2 was rated relatively higher, based on its ease of understanding, entertainment value, usefulness and the appropriateness of use of its emotional glossary.Discussion: Improvements were observed in prosodic recognition following intervention with Voices 2 in the Voices group. Although these results are similar to other clinical trial rehabilitation programs, specific research on the matter remains scarce. Certain aspects, such as the durability of effects or adherence should be thoroughly studied and clarified.Clinical Trial Registration: [https://doi.org/10.17605/OSF.IO/G95C4].

Effect of Aquatic Exercise on Sleep Efficiency of Adults With Chronic Musculoskeletal Pain

2021 ◽  
pp. 1-9
Author(s):  
Billy C.L. So ◽  
Sze C. Kwok ◽  
Paul H. Lee
Keyword(s):  
Intervention Group ◽  
Exercise Program ◽  
Sleep Time ◽  
Sleep Efficiency ◽  
Activity Level ◽  
Aquatic Exercise ◽  
Moderate Intensity ◽  
Control Group ◽  
Before And After ◽  
And Control

Background: Aerobic exercise improves sleep for people who have difficulty in sleeping soundly, but most research to date has focused on land-based exercise. There has been only very limited research into the effect of aquatic exercise on people with chronic musculoskeletal (MSK) pain. The purpose of this study is to examine the effect of a 6-week aquatic exercise program on sleep efficiency among adults with chronic MSK pain. Methods: A total of 30 adults with chronic MSK pain were recruited by convenience sampling and assigned into intervention and control groups by a trained research assistant. Their sleep efficiency, sleep quality, activity level, stress level, and pain level were measured with ActiGraph GT3X accelerometer before and after the intervention group completed a 6-week, biweekly program of aquatic exercise. Results: Following intervention, the intervention group had significantly longer total true sleep time (by 27.6 min, P = .006); greater sleep efficiency (+3.01%, P = .005); and less pain (−1.33/10, P = .026). The control group had significantly shorter total true sleep time by 5.8 minutes (P = .036) while changes in the other outcomes were not significant. Conclusions: Six weeks of moderate-intensity aquatic exercise may improve sleep efficiency and reduce pain for persons suffering chronic MSK pain.

scholarly journals Impact of Vigorous exercise on serum levels of L-Carnitine in prisoners in Colombia

2016 ◽  
Vol 17 (5) ◽  
pp. 689-698 ◽  
Author(s):  
Angel Francisco Acevedo Pabón ◽  
Fred Gustavo Manrique-Abril ◽  
Juan Manuel Ospina-Diaz
Keyword(s):  
Intervention Group ◽  
Exercise Program ◽  
Serum Levels ◽  
Population Based ◽  
Control Group ◽  
Routine Practice ◽  
Post Intervention ◽  
Vigorous Exercise ◽  
Anthropometric Measures ◽  
Male Inmates

<p>To assess the effect of a program of vigorous physical exercises on the serum concentration of free and total L-carnitine, in male inmates at a prison in Boyacá, Colombia.</p><p><strong>Methods</strong> Pre-post intervention population-based study. 44 male prisoners with overweight and/or obesity, from a jail in Boyacá, Colombia were randomly assigned into two groups: an intervention group and a control group. The intervention consisted in participating in a vigorous exercise program over twelve weeks. Anthropometric measures and levels of free and total L-carnitine were every four weeks.</p><p><strong>Results</strong> There were significant increases in serum levels of free and total L-carnitine in the intervention group compared to the control group. Concurrently, in this group there was a reduction in body mass index (BMI), while in the control group there were no changes.</p><p><strong>Conclusion</strong> In overweight and/or obese patients, the routine practice of vigorous exercise plus caloric restriction offers significant benefits in reducing body fat volumes through the mechanisms of energetic consumption of long chain fatty acids.</p>

scholarly journals Efficacy of a Low Dose of Melatonin as an Adjunctive Therapy in Hospitalized Patients with COVID-19: A Randomized, Double-blind Clinical Trial

2020 ◽  
Author(s):  
Gholamreza Farnoosh ◽  
Mostafa Akbariqomi ◽  
Taleb Badri ◽  
Mahdi Bagheri ◽  
Morteza Izadi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adjunctive Therapy ◽  
Clinical Symptoms ◽  
Intervention Group ◽  
Standard Of Care ◽  
Hospitalized Patients ◽  
Control Group ◽  
Post Intervention ◽  
Double Blind ◽  
Baseline Health

Abstract Aim: To evaluate the clinical efficacy of adjuvant use of melatonin in patients with coronavirus disease 2019 (COVID-19). Methods: This single-center, double-blind, randomized clinical trial included 74 hospitalized patients with confirmed mild to moderate COVID-19 at Baqiyatallah Hospital in Tehran, Iran, from April 25, 2020 to June 5, 2020. Patients were randomly assigned in a 1:1 ratio to receive standard of care and standard of care plus melatonin at a dose of 3 mg three times daily for 14 days. Clinical characteristics, laboratory, and radiological findings were assessed and compared between two study groups at baseline and post-intervention. Safety and clinical outcomes were followed up for four weeks. Results: A total of 24 patients in the intervention group and 20 patients in the control group completed the treatment. Compared with the control group, the clinical symptoms such as cough, dyspnea, and fatigue, as well as the level of CRP and the pulmonary involvement in the intervention group had significantly improved (P < 0.05). The mean time of hospital discharge of patients and return to baseline health was significantly shorter in the intervention group compared to the control group (P < 0.05). No deaths and adverse events were observed in both groups during this study. Conclusions: Adjuvant use of melatonin has a potential to improve clinical symptoms of COVID-19 patients and contribute to a faster return of patients to baseline health. Keywords: COVID-19, Melatonin, Clinical trial, Adjunctive therapy Trial Registration: ClinicalTrials.gov Identifier: NCT04409522

scholarly journals Push Notifications From a Mobile App to Improve the Body Composition of Overweight or Obese Women: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Alberto Hernández-Reyes ◽  
Fernando Cámara-Martos ◽  
Guillermo Molina Recio ◽  
Rafael Molina-Luque ◽  
Manuel Romero-Saldaña ◽  
...  
Keyword(s):  
Physical Activity ◽  
Clinical Trial ◽  
Weight Loss ◽  
Body Composition ◽  
Controlled Trial ◽  
Intervention Group ◽  
The Body ◽  
Control Group ◽  
Obese Women ◽  
Randomized Controlled

BACKGROUND Technology—in particular, access to the Internet from a mobile device—has forever changed the way we relate to others and how we behave in our daily life settings. In recent years, studies have been carried out to analyze the effectiveness of different actions via mobile phone in the field of health: telephone calls, short message service (SMS), telemedicine, and, more recently, the use of push notifications. We have continued to explore ways to increase user interaction with mobile apps, one of the pending subjects in the area of mHealth. By analyzing the data produced by subjects during a clinical trial, we were able to extract behavior patterns and, according to them, design effective protocols in weight loss programs. OBJECTIVE A clinical trial was proposed to (1) evaluate the efficacy of push notifications in an intervention aimed at improving the body composition of adult women who are overweight or obese, through a dietary procedure, and (2) analyze the evolution of body composition based on push notifications and prescribed physical activity (PA). METHODS A two-arm randomized controlled trial was carried out. A sample size of 117 adult obese women attended a face-to-face, 30-minute consultation once a week for 6 months. All patients were supplied with an app designed for this study and a pedometer. The control group did not have access to functionalities related to the self-monitoring of weight at home, gamification, or prescription of PA. The intervention group members were assigned objectives to achieve a degree of compliance with diet and PA through exclusive access to specific functionalities of the app and push notifications. The same diet was prescribed for all patients. Three possible PA scenarios were studied for both the control and intervention groups: light physical activity (LPA), moderate physical activity (MPA), and intense physical activity (IPA). For the analysis of three or more means, the analysis of variance (ANOVA) of repeated means was performed to evaluate the effects of the intervention at baseline and at 3 and 6 months. RESULTS Receiving notifications during the intervention increased body fat loss (mean -12.9% [SD 6.7] in the intervention group vs mean -7.0% [SD 5.7] in the control group; <i>P</i>&lt;.001) and helped to maintain muscle mass (mean -0.8% [SD 4.5] in the intervention group vs mean -3.2% [SD 2.8] in the control group; <i>P</i>&lt;.018). These variations between groups led to a nonsignificant difference in weight loss (mean -7.9 kg [SD 3.9] in the intervention group vs mean -7.1 kg [SD 3.4] in the control group; <i>P</i>&gt;.05). CONCLUSIONS Push notifications have proven effective in the proposed weight loss program, leading women who received them to achieve greater loss of fat mass and a maintenance or increase of muscle mass, specifically among those who followed a program of IPA. Future interventions should include a longer evaluation period; the impact of different message contents, as well as message delivery times and frequency, should also be researched. CLINICALTRIAL ClinicalTrials.gov NCT03911583; https://www.clinicaltrials.gov/ct2/show/NCT03911583

scholarly journals LAVENDER ESSENTIAL OIL FOR SPINAL PAIN IN OBESE WOMEN: A CLINICAL TRIAL

2021 ◽  
Vol 20 (3) ◽  
pp. 192-196
Author(s):  
MARIANA FELIN CEREZER ◽  
SHEILA SPOHR NEDEL ◽  
MORGANA CHRISTMANN ◽  
LARISSA SANTOS NUNES ◽  
IGOR SOARES VIEIRA ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Essential Oil ◽  
Positive Impact ◽  
Intervention Group ◽  
Spinal Pain ◽  
Cervical Region ◽  
Control Group ◽  
Lumbar Region ◽  
Obese Women ◽  
Level Of Evidence

ABSTRACT Objective To analyze the effect of lavender essential oil associated with massage on spinal pain levels in obese women. Methods The sample included 49 obese women, between 20 and 60 years of age, randomly assigned to three groups: control (n=15), intervention (n=19) and placebo (n=15). The intervention and placebo groups were submitted to eight 35-minute sessions, twice a week for one month, but the essential oil of Lavandula angustifolia was used only in the intervention group. A placebo was used for the placebo group and the control group received no intervention. Pain levels were measured before and after the intervention using the Visual Analog Scale. Results There was a significant decrease in total spinal pain (p=0.004), in the cervical region (p=0.003) and in the lumbar region (p=0.008) in the intervention group. Conclusion Lavender essential oil had a positive impact on the reduction of pain in the spine of obese women, as well as in the specific areas of the cervical and lumbar regions compared to the control and placebo groups. Level of evidence I; Randomized clinical trial.

Do exercises improve back pain in pregnancy?

2017 ◽  
Vol 32 (3) ◽  
Author(s):  
Muhammad Azrai Abu ◽  
Nur Azurah Abdul Ghani ◽  
Lim Pei Shan ◽  
Aqmar Suraya Sulaiman ◽  
Mohd Hashim Omar ◽  
...  
Keyword(s):  
Back Pain ◽  
Pregnant Women ◽  
Pain Intensity ◽  
Functional Limitation ◽  
Intervention Group ◽  
Exercise Program ◽  
Control Group ◽  
Prospective Control Study ◽  
Post Intervention ◽  
Back Care

AbstractObjectiveTo assess the efficacy of an exercise program towards reducing back pain in pregnant women.MethodsIn this prospective control study, 145 low risk pregnant women who scored more than 20 for functional limitation assessment were recruited. The severity of back pain was assessed using the visual analoque scale (VAS) and the functional limitation was assessed using the Oswestry disability questionnaire (ODQ). All participants were informed of back care measures and provided with Paracetamol as an adjunct analgesia. The intervention group will have a session with a trained physiotherapist. Subsequently, all participants will be required to fill in a similar questionnaire regarding pain intensity and functional limitation assessment after 6 weeks post-intervention.ResultsThere was a significant reduction in the VAS score and improvement in functional ODQ score in the intervention group. The median usage of Paracetamol as an analgesia to control back pain in the control group was 500 mg higher than the intervention group. There was a weak association of age, parity, duration of back pain, and body mass index with functional ODQ score at 6 week following intervention.ConclusionThe back pain exercise reducing program was effective in reducing back pain intensity and analgesia usage with a significant improvement in functional ability.

scholarly journals The effect of specific nutritional modification program on specific liver findings in children with chronic liver disease: A clinical trial

2020 ◽  
Author(s):  
SeyedAli Jafari ◽  
Aramesh Rezaeian ◽  
Zahra Nomjuo ◽  
Majid Ghayour-Mobarhan ◽  
Zahra ghaneifar
Keyword(s):  
Clinical Trial ◽  
Liver Disease ◽  
Chronic Liver Disease ◽  
Age Of Onset ◽  
Intervention Group ◽  
Chronic Liver ◽  
Control Group ◽  
Post Intervention ◽  
Adjustment Program ◽  
The Mean

Abstract Background: Liver disease leads to complex pathophysiological injuries that affect digestion, absorption, distribution, storage and use of food. The effect that chronic liver disease has on the nutritional status and health of the child is determined by the cause and severity of liver disease and the age of onset of liver disease. As liver disease progresses, so do the symptoms and complications of the disease. The aim of this study was to determine the effect of specific nutrition adjustment program on specific liver findings in children with chronic liver disease.Methods: In this clinical trial study, 75 children with chronic liver disease were randomly divided into two groups (45 in the intervention group and 30 in the control group). At the beginning of the study, the necessary experiments were taken from two groups. The intervention group received a nutritional adjustment program during 6 sessions of the workshop. After 12 weeks of follow-up, bilirubin level (total, direct), albumin level, PT, INR, transaminases (AST, ALT) were measured in both groups. Data analysis was performed using SPSS software version 16 and Wilcoxon and Mann-Whitney tests.Results: At the beginning of the study, both groups were homogeneous in terms of demographic variables. In the post-intervention stage compared to the pre-intervention stage in the intervention group, the mean scores of prothrombin time (P = 0/040), albumin (P = 0/007), aspartate transaminase and alanine transaminase (p˂0/001)were statistically significant:. But the mean score of total bilirubin (P = 0/063) in the post-intervention stage compared to before the intervention in the intervention group was not statistically significant.Conclusion: Nutrition education and encouragement of patients with chronic liver disease to follow a special diet can be an important factor in feeling healthy and preventing the progression of the disease.Trial registration: Name of registry: Zahra NamjouIRCT registration number: IRCT2015091424019N1 Registration date: 2016-01-30 Registration timing: retrospective

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